Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03786380
Registration number
NCT03786380
Ethics application status
Date submitted
21/12/2018
Date registered
26/12/2018
Titles & IDs
Public title
Diabetic Gastroparesis Study 05
Query!
Scientific title
Open-label Extension Study of Relamorelin for the Treatment of Diabetic Gastroparesis
Query!
Secondary ID [1]
0
0
2019-000406-30
Query!
Secondary ID [2]
0
0
3071-305-020
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Gastroparesis
0
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Neurological
0
0
0
0
Query!
Other neurological disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Relamorelin 10 µg
Experimental: Relamorelin 10 µg - Relamorelin 10 micrograms (µg) injected subcutaneously twice daily for up to approximately 22 months.
Treatment: Drugs: Relamorelin 10 µg
Relamorelin 10 µg injected subcutaneously twice daily.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)
Query!
Assessment method [1]
0
0
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.
Query!
Timepoint [1]
0
0
Up to approximately 22 months
Query!
Primary outcome [2]
0
0
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Query!
Assessment method [2]
0
0
Clinical Laboratory tests included hematology, chemistry and urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
Query!
Timepoint [2]
0
0
Baseline (Day 1) up to approximately 22 months
Query!
Primary outcome [3]
0
0
Number of Participants With Clinically Meaningful Trends for Vital Signs
Query!
Assessment method [3]
0
0
Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant.
Query!
Timepoint [3]
0
0
Up to approximately 22 months
Query!
Primary outcome [4]
0
0
Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results
Query!
Assessment method [4]
0
0
A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
Query!
Timepoint [4]
0
0
Up to approximately 22 months
Query!
Eligibility
Key inclusion criteria
* Successful completion of either Study RLM-MD-03 or Study RLM-MD-04
* Ability to provide written informed consent (IC) prior to any study procedures and willingness and ability to comply with study procedures
* Demonstration of adequate compliance with the study procedures in Study RLM-MD-03 or RLM-MD-04, in the opinion of the investigator.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study 3071-305-020
* Participant has an unresolved adverse event (AE) from a lead-in study, ie, a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study
* Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic, or cardiopulmonary disease
* Females who are pregnant, nursing, or planning a pregnancy during the study.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
20/12/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
5/10/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
202
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Nepean Hospital - Kingswood
Query!
Recruitment hospital [2]
0
0
Princess Alexandra Hospital - Woolloongabba
Query!
Recruitment hospital [3]
0
0
Royal Adelaide Hospital - Central Adelaide Local Health Network Incorporated - Adelaide
Query!
Recruitment hospital [4]
0
0
The Alfred Hospital - Melbourne
Query!
Recruitment hospital [5]
0
0
Royal Melbourne Hospital - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2747 - Kingswood
Query!
Recruitment postcode(s) [2]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [3]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [4]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [5]
0
0
3050 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Colorado
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Connecticut
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Florida
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Georgia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Idaho
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Illinois
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Indiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Iowa
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Kansas
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Kentucky
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Louisiana
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Maryland
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Massachusetts
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Michigan
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Minnesota
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Missouri
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Montana
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Nebraska
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Nevada
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
New Jersey
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
New Mexico
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
New York
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
North Carolina
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Ohio
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Oklahoma
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Pennsylvania
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Rhode Island
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
South Carolina
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
South Dakota
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Tennessee
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
Texas
Query!
Country [36]
0
0
United States of America
Query!
State/province [36]
0
0
Utah
Query!
Country [37]
0
0
United States of America
Query!
State/province [37]
0
0
Virginia
Query!
Country [38]
0
0
United States of America
Query!
State/province [38]
0
0
Washington
Query!
Country [39]
0
0
United States of America
Query!
State/province [39]
0
0
West Virginia
Query!
Country [40]
0
0
Argentina
Query!
State/province [40]
0
0
Buenos Aires Province
Query!
Country [41]
0
0
Argentina
Query!
State/province [41]
0
0
Santa Fe
Query!
Country [42]
0
0
Argentina
Query!
State/province [42]
0
0
Corrientes
Query!
Country [43]
0
0
Austria
Query!
State/province [43]
0
0
Steiermark
Query!
Country [44]
0
0
Austria
Query!
State/province [44]
0
0
Tirol
Query!
Country [45]
0
0
Austria
Query!
State/province [45]
0
0
Vorarlberg
Query!
Country [46]
0
0
Austria
Query!
State/province [46]
0
0
Klagenfurt
Query!
Country [47]
0
0
Austria
Query!
State/province [47]
0
0
Salzburg
Query!
Country [48]
0
0
Austria
Query!
State/province [48]
0
0
Steyr
Query!
Country [49]
0
0
Austria
Query!
State/province [49]
0
0
Vienna
Query!
Country [50]
0
0
Belgium
Query!
State/province [50]
0
0
Antwerpen
Query!
Country [51]
0
0
Belgium
Query!
State/province [51]
0
0
Brussels
Query!
Country [52]
0
0
Belgium
Query!
State/province [52]
0
0
Jette
Query!
Country [53]
0
0
Belgium
Query!
State/province [53]
0
0
Liège
Query!
Country [54]
0
0
Brazil
Query!
State/province [54]
0
0
Ceara
Query!
Country [55]
0
0
Brazil
Query!
State/province [55]
0
0
Distrito Federal
Query!
Country [56]
0
0
Brazil
Query!
State/province [56]
0
0
Parana
Query!
Country [57]
0
0
Brazil
Query!
State/province [57]
0
0
Para
Query!
Country [58]
0
0
Brazil
Query!
State/province [58]
0
0
Rio Grande Do Sul
Query!
Country [59]
0
0
Brazil
Query!
State/province [59]
0
0
Santa Catarina
Query!
Country [60]
0
0
Brazil
Query!
State/province [60]
0
0
Sao Paulo
Query!
Country [61]
0
0
Brazil
Query!
State/province [61]
0
0
Fortaleza
Query!
Country [62]
0
0
Bulgaria
Query!
State/province [62]
0
0
Byala
Query!
Country [63]
0
0
Bulgaria
Query!
State/province [63]
0
0
Dobrich
Query!
Country [64]
0
0
Bulgaria
Query!
State/province [64]
0
0
Gabrovo
Query!
Country [65]
0
0
Bulgaria
Query!
State/province [65]
0
0
Plovdiv
Query!
Country [66]
0
0
Bulgaria
Query!
State/province [66]
0
0
Sofia
Query!
Country [67]
0
0
Canada
Query!
State/province [67]
0
0
Alberta
Query!
Country [68]
0
0
Canada
Query!
State/province [68]
0
0
British Columbia
Query!
Country [69]
0
0
Canada
Query!
State/province [69]
0
0
Newfoundland and Labrador
Query!
Country [70]
0
0
Canada
Query!
State/province [70]
0
0
Nova Scotia
Query!
Country [71]
0
0
Canada
Query!
State/province [71]
0
0
Ontario
Query!
Country [72]
0
0
Canada
Query!
State/province [72]
0
0
Quebec
Query!
Country [73]
0
0
Canada
Query!
State/province [73]
0
0
Red Deer
Query!
Country [74]
0
0
Canada
Query!
State/province [74]
0
0
Vaughan
Query!
Country [75]
0
0
Colombia
Query!
State/province [75]
0
0
Antioquia
Query!
Country [76]
0
0
Colombia
Query!
State/province [76]
0
0
Atlántico
Query!
Country [77]
0
0
Colombia
Query!
State/province [77]
0
0
Cundinamarca
Query!
Country [78]
0
0
Colombia
Query!
State/province [78]
0
0
Distrito Capltal
Query!
Country [79]
0
0
Colombia
Query!
State/province [79]
0
0
Valle Del Cauca
Query!
Country [80]
0
0
Denmark
Query!
State/province [80]
0
0
Kobenhavn
Query!
Country [81]
0
0
Denmark
Query!
State/province [81]
0
0
Aalborg
Query!
Country [82]
0
0
Denmark
Query!
State/province [82]
0
0
Hellerup
Query!
Country [83]
0
0
Denmark
Query!
State/province [83]
0
0
Hilleroed
Query!
Country [84]
0
0
Denmark
Query!
State/province [84]
0
0
Århus
Query!
Country [85]
0
0
France
Query!
State/province [85]
0
0
Gironde
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Colombes
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Corbeil Essonnes
Query!
Country [88]
0
0
France
Query!
State/province [88]
0
0
Grenoble
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
LYON Cedex 03
Query!
Country [90]
0
0
France
Query!
State/province [90]
0
0
Nantes
Query!
Country [91]
0
0
France
Query!
State/province [91]
0
0
Poitiers
Query!
Country [92]
0
0
France
Query!
State/province [92]
0
0
Rouen Cedex
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Vandoeuvre-lès-Nancy
Query!
Country [94]
0
0
France
Query!
State/province [94]
0
0
Venissieux
Query!
Country [95]
0
0
Germany
Query!
State/province [95]
0
0
Baden-Württemberg
Query!
Country [96]
0
0
Germany
Query!
State/province [96]
0
0
Mecklenburg-Western Pomerania
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
North Rhine-Westphalia
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Saxony
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Böhlen
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Giessen
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Hamburg
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Hannover
Query!
Country [103]
0
0
Hungary
Query!
State/province [103]
0
0
Heves
Query!
Country [104]
0
0
Hungary
Query!
State/province [104]
0
0
Pécs
Query!
Country [105]
0
0
Hungary
Query!
State/province [105]
0
0
Szaged
Query!
Country [106]
0
0
Hungary
Query!
State/province [106]
0
0
Zala
Query!
Country [107]
0
0
Hungary
Query!
State/province [107]
0
0
Budapest
Query!
Country [108]
0
0
Hungary
Query!
State/province [108]
0
0
Szolnok
Query!
Country [109]
0
0
India
Query!
State/province [109]
0
0
Andhra Pradesh
Query!
Country [110]
0
0
India
Query!
State/province [110]
0
0
Gujarat
Query!
Country [111]
0
0
India
Query!
State/province [111]
0
0
Karnataka
Query!
Country [112]
0
0
India
Query!
State/province [112]
0
0
Maharashtra
Query!
Country [113]
0
0
India
Query!
State/province [113]
0
0
Rajasthan
Query!
Country [114]
0
0
India
Query!
State/province [114]
0
0
Tamil Nadu
Query!
Country [115]
0
0
India
Query!
State/province [115]
0
0
Uttar Pradesh
Query!
Country [116]
0
0
India
Query!
State/province [116]
0
0
West Bengal
Query!
Country [117]
0
0
India
Query!
State/province [117]
0
0
Bangalore
Query!
Country [118]
0
0
India
Query!
State/province [118]
0
0
Hyderabad
Query!
Country [119]
0
0
India
Query!
State/province [119]
0
0
Mumbai
Query!
Country [120]
0
0
Israel
Query!
State/province [120]
0
0
Beer Sheva
Query!
Country [121]
0
0
Israel
Query!
State/province [121]
0
0
Haifa
Query!
Country [122]
0
0
Israel
Query!
State/province [122]
0
0
Holon
Query!
Country [123]
0
0
Israel
Query!
State/province [123]
0
0
Jerusalem
Query!
Country [124]
0
0
Israel
Query!
State/province [124]
0
0
Petach Tikva
Query!
Country [125]
0
0
Israel
Query!
State/province [125]
0
0
Safed
Query!
Country [126]
0
0
Israel
Query!
State/province [126]
0
0
Tel Aviv
Query!
Country [127]
0
0
Italy
Query!
State/province [127]
0
0
Milan
Query!
Country [128]
0
0
Italy
Query!
State/province [128]
0
0
Pavia
Query!
Country [129]
0
0
Italy
Query!
State/province [129]
0
0
Rome Roma
Query!
Country [130]
0
0
Italy
Query!
State/province [130]
0
0
Asti
Query!
Country [131]
0
0
Italy
Query!
State/province [131]
0
0
Bari
Query!
Country [132]
0
0
Italy
Query!
State/province [132]
0
0
Catania
Query!
Country [133]
0
0
Italy
Query!
State/province [133]
0
0
Catanzaro
Query!
Country [134]
0
0
Italy
Query!
State/province [134]
0
0
Genova
Query!
Country [135]
0
0
Italy
Query!
State/province [135]
0
0
Napoli
Query!
Country [136]
0
0
Italy
Query!
State/province [136]
0
0
Padova
Query!
Country [137]
0
0
Italy
Query!
State/province [137]
0
0
Pisa
Query!
Country [138]
0
0
Italy
Query!
State/province [138]
0
0
Rozzano
Query!
Country [139]
0
0
Italy
Query!
State/province [139]
0
0
Salerno
Query!
Country [140]
0
0
Italy
Query!
State/province [140]
0
0
San Giovanni Rotondo
Query!
Country [141]
0
0
Korea, Republic of
Query!
State/province [141]
0
0
Jeollabuk-do
Query!
Country [142]
0
0
Korea, Republic of
Query!
State/province [142]
0
0
Seoul
Query!
Country [143]
0
0
Latvia
Query!
State/province [143]
0
0
Daugavpils
Query!
Country [144]
0
0
Latvia
Query!
State/province [144]
0
0
Kraslava
Query!
Country [145]
0
0
Latvia
Query!
State/province [145]
0
0
Riga
Query!
Country [146]
0
0
Malaysia
Query!
State/province [146]
0
0
Kedah
Query!
Country [147]
0
0
Malaysia
Query!
State/province [147]
0
0
Kuala Lumpur
Query!
Country [148]
0
0
Malaysia
Query!
State/province [148]
0
0
Kubang Kerian
Query!
Country [149]
0
0
Malaysia
Query!
State/province [149]
0
0
Taiping
Query!
Country [150]
0
0
Mexico
Query!
State/province [150]
0
0
Distrito Federal
Query!
Country [151]
0
0
Mexico
Query!
State/province [151]
0
0
Guanajuato
Query!
Country [152]
0
0
Mexico
Query!
State/province [152]
0
0
Hidalgo
Query!
Country [153]
0
0
Mexico
Query!
State/province [153]
0
0
Jalisco
Query!
Country [154]
0
0
Mexico
Query!
State/province [154]
0
0
Morelos
Query!
Country [155]
0
0
Mexico
Query!
State/province [155]
0
0
Nuevo Leon
Query!
Country [156]
0
0
Mexico
Query!
State/province [156]
0
0
Sonora
Query!
Country [157]
0
0
Mexico
Query!
State/province [157]
0
0
Veracruz
Query!
Country [158]
0
0
Mexico
Query!
State/province [158]
0
0
Yucatan
Query!
Country [159]
0
0
Mexico
Query!
State/province [159]
0
0
Acapulco
Query!
Country [160]
0
0
Mexico
Query!
State/province [160]
0
0
Aguascalientes
Query!
Country [161]
0
0
Mexico
Query!
State/province [161]
0
0
Durango
Query!
Country [162]
0
0
Philippines
Query!
State/province [162]
0
0
Cebu City
Query!
Country [163]
0
0
Philippines
Query!
State/province [163]
0
0
IloIlo City
Query!
Country [164]
0
0
Philippines
Query!
State/province [164]
0
0
Makati City
Query!
Country [165]
0
0
Philippines
Query!
State/province [165]
0
0
Manila
Query!
Country [166]
0
0
Philippines
Query!
State/province [166]
0
0
Pasay
Query!
Country [167]
0
0
Philippines
Query!
State/province [167]
0
0
Quezon City
Query!
Country [168]
0
0
Philippines
Query!
State/province [168]
0
0
San Juan
Query!
Country [169]
0
0
Poland
Query!
State/province [169]
0
0
Bia
Query!
Country [170]
0
0
Poland
Query!
State/province [170]
0
0
Warazawa
Query!
Country [171]
0
0
Poland
Query!
State/province [171]
0
0
Bialystok
Query!
Country [172]
0
0
Poland
Query!
State/province [172]
0
0
Bydgoszcz
Query!
Country [173]
0
0
Poland
Query!
State/province [173]
0
0
Chojnice
Query!
Country [174]
0
0
Poland
Query!
State/province [174]
0
0
Katowice
Query!
Country [175]
0
0
Poland
Query!
State/province [175]
0
0
Krakow
Query!
Country [176]
0
0
Poland
Query!
State/province [176]
0
0
Kraków
Query!
Country [177]
0
0
Poland
Query!
State/province [177]
0
0
Lublin
Query!
Country [178]
0
0
Poland
Query!
State/province [178]
0
0
Olsztyn
Query!
Country [179]
0
0
Poland
Query!
State/province [179]
0
0
Pruszków
Query!
Country [180]
0
0
Poland
Query!
State/province [180]
0
0
Sopot
Query!
Country [181]
0
0
Poland
Query!
State/province [181]
0
0
Wolów
Query!
Country [182]
0
0
Poland
Query!
State/province [182]
0
0
Wroclaw
Query!
Country [183]
0
0
Poland
Query!
State/province [183]
0
0
Zamosc
Query!
Country [184]
0
0
Romania
Query!
State/province [184]
0
0
Bucharest
Query!
Country [185]
0
0
Romania
Query!
State/province [185]
0
0
Calarasi
Query!
Country [186]
0
0
Romania
Query!
State/province [186]
0
0
Dobrosloveni Resca, Olt County
Query!
Country [187]
0
0
Romania
Query!
State/province [187]
0
0
Sibiu
Query!
Country [188]
0
0
Russian Federation
Query!
State/province [188]
0
0
Novosibirskaya Oblast
Query!
Country [189]
0
0
Russian Federation
Query!
State/province [189]
0
0
Sankt-Peterburg
Query!
Country [190]
0
0
Russian Federation
Query!
State/province [190]
0
0
Kazan
Query!
Country [191]
0
0
Russian Federation
Query!
State/province [191]
0
0
Leningrad Region
Query!
Country [192]
0
0
Russian Federation
Query!
State/province [192]
0
0
Moscow
Query!
Country [193]
0
0
Russian Federation
Query!
State/province [193]
0
0
Nizhny
Query!
Country [194]
0
0
Russian Federation
Query!
State/province [194]
0
0
Rostov on Don
Query!
Country [195]
0
0
Russian Federation
Query!
State/province [195]
0
0
Rostov-on-Don
Query!
Country [196]
0
0
Russian Federation
Query!
State/province [196]
0
0
Saratov
Query!
Country [197]
0
0
Singapore
Query!
State/province [197]
0
0
Singapore
Query!
Country [198]
0
0
South Africa
Query!
State/province [198]
0
0
Free State
Query!
Country [199]
0
0
South Africa
Query!
State/province [199]
0
0
Gauteng
Query!
Country [200]
0
0
South Africa
Query!
State/province [200]
0
0
Western Cape
Query!
Country [201]
0
0
South Africa
Query!
State/province [201]
0
0
Brandfort
Query!
Country [202]
0
0
South Africa
Query!
State/province [202]
0
0
Cape Town
Query!
Country [203]
0
0
South Africa
Query!
State/province [203]
0
0
Val De Grace
Query!
Country [204]
0
0
Spain
Query!
State/province [204]
0
0
Madrid
Query!
Country [205]
0
0
Spain
Query!
State/province [205]
0
0
Salamanca
Query!
Country [206]
0
0
Spain
Query!
State/province [206]
0
0
Sevilla
Query!
Country [207]
0
0
Spain
Query!
State/province [207]
0
0
Zaragoza
Query!
Country [208]
0
0
Thailand
Query!
State/province [208]
0
0
Bangkok
Query!
Country [209]
0
0
Thailand
Query!
State/province [209]
0
0
Chiang Mai
Query!
Country [210]
0
0
Ukraine
Query!
State/province [210]
0
0
Dnipropetrovs'ka Oblast
Query!
Country [211]
0
0
Ukraine
Query!
State/province [211]
0
0
Ivano-Frankivs'ka Oblast'
Query!
Country [212]
0
0
Ukraine
Query!
State/province [212]
0
0
Kyïv
Query!
Country [213]
0
0
Ukraine
Query!
State/province [213]
0
0
Vinnyts'ka Oblast'
Query!
Country [214]
0
0
Ukraine
Query!
State/province [214]
0
0
Volyos'ka Oblast'
Query!
Country [215]
0
0
Ukraine
Query!
State/province [215]
0
0
Chernihiv
Query!
Country [216]
0
0
Ukraine
Query!
State/province [216]
0
0
Chernivtsi
Query!
Country [217]
0
0
Ukraine
Query!
State/province [217]
0
0
Dnipro
Query!
Country [218]
0
0
Ukraine
Query!
State/province [218]
0
0
Ivano-Frankivsk
Query!
Country [219]
0
0
Ukraine
Query!
State/province [219]
0
0
Kharkiv
Query!
Country [220]
0
0
Ukraine
Query!
State/province [220]
0
0
Kherson
Query!
Country [221]
0
0
Ukraine
Query!
State/province [221]
0
0
Kyiv
Query!
Country [222]
0
0
Ukraine
Query!
State/province [222]
0
0
Mykolaiv
Query!
Country [223]
0
0
Ukraine
Query!
State/province [223]
0
0
Odesa
Query!
Country [224]
0
0
Ukraine
Query!
State/province [224]
0
0
Poltava
Query!
Country [225]
0
0
Ukraine
Query!
State/province [225]
0
0
Sumy
Query!
Country [226]
0
0
Ukraine
Query!
State/province [226]
0
0
Ternopil
Query!
Country [227]
0
0
Ukraine
Query!
State/province [227]
0
0
Vinnytsia
Query!
Country [228]
0
0
Ukraine
Query!
State/province [228]
0
0
Zaporizhzhia
Query!
Country [229]
0
0
United Kingdom
Query!
State/province [229]
0
0
Lancashire
Query!
Country [230]
0
0
United Kingdom
Query!
State/province [230]
0
0
Staffordshire
Query!
Country [231]
0
0
United Kingdom
Query!
State/province [231]
0
0
Barnsley
Query!
Country [232]
0
0
United Kingdom
Query!
State/province [232]
0
0
Blackpool
Query!
Country [233]
0
0
United Kingdom
Query!
State/province [233]
0
0
Chelmsford
Query!
Country [234]
0
0
United Kingdom
Query!
State/province [234]
0
0
Edinburgh
Query!
Country [235]
0
0
United Kingdom
Query!
State/province [235]
0
0
Leeds
Query!
Country [236]
0
0
United Kingdom
Query!
State/province [236]
0
0
Liverpool
Query!
Country [237]
0
0
United Kingdom
Query!
State/province [237]
0
0
London
Query!
Country [238]
0
0
United Kingdom
Query!
State/province [238]
0
0
Manchester
Query!
Country [239]
0
0
United Kingdom
Query!
State/province [239]
0
0
Newcastle upon Tyne
Query!
Country [240]
0
0
United Kingdom
Query!
State/province [240]
0
0
Nottingham
Query!
Country [241]
0
0
United Kingdom
Query!
State/province [241]
0
0
Stockton-on-Tees
Query!
Country [242]
0
0
United Kingdom
Query!
State/province [242]
0
0
Tooting
Query!
Country [243]
0
0
United Kingdom
Query!
State/province [243]
0
0
Wolverhampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Allergan
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This open-label study is to assess the safety of continued treatment with relamorelin for participants who previously completed the RLM-MD-03 \[NCT03420781\] or RLM-MD-04 \[NCT03383146\] study and to provide treatment for these participants until relamorelin becomes commercially available or the Sponsor terminates development.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03786380
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Harvy Schneier
Query!
Address
0
0
Allergan
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/80/NCT03786380/Prot_002.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/80/NCT03786380/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03786380