Trial Review

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/ct2/show/NCT01384292




Registration number
NCT01384292
Ethics application status
Date submitted
28/06/2011
Date registered
29/06/2011
Date last updated
1/06/2015

Titles & IDs
Public title
Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Relieving Opioid-Induced Constipation (OIC) in Patients With Cancer-Related Pain
Secondary ID [1] 0 0
2011-001985-16
Secondary ID [2] 0 0
D3820C00006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid-Induced Constipation 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Mental Health 0 0 0 0
Addiction
Cancer 0 0 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NKTR-118
Treatment: Drugs - NKTR-118
Treatment: Drugs - Placebo

Experimental: 1 (part A and B) - Oral treatment

Experimental: 2 (part A and B) - Oral treatment

Placebo Comparator: 3 (part A only) - Oral treatment


Treatment: Drugs: NKTR-118
12.5 mg oral tablet once daily

Treatment: Drugs: NKTR-118
25 mg oral tablet once daily

Treatment: Drugs: Placebo
Oral treatment
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Response (Responder/Non-responder) to Study Drug
Timepoint [1] 0 0
Baseline to Week 4

Eligibility
Key inclusion criteria
- Provision of written informed consent prior to any study-specific procedures.

- Men and women aged 18 or older.

- Histologically or cytologically confirmed neoplasm causing pain and requiring
management with opioids.

- Self-reported active symptoms of OIC at screening (<3 RFBMs/week and experiencing >1
reported symptom of hard/lumpy stools, straining, or sensation of incomplete
evacuation/anorectal obstruction in at least 25% of BMs over the previous 4 weeks);
and Documented confirmed OIC (<3 RFBMs/week on average aver the 2-week OIC
confirmation period.

- Receiving a stable maintenance opioid regimen consisting of a total daily dose of >30
mg of oral morphine, or equianalgesic amount(s) of 1 or more opioid therapies for a
minimum of 4 weeks prior to screening for cancer-related pain with no anticipated
change in opioid dose requirement over the proposed study period as a result of
disease progression.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients receiving Opioid regimen for treatment of pain other than related to cancer.

- Any condition that may have affected the permeability of the blood-brain barrier, eg,
known brain metastases, meningeal metastases, brain injury, multiple sclerosis, recent
brain injury, uncontrolled epilepsy.

- Patients with cancer-related pain due to ovarian cancer, leukaemia, or lymphoma are
excluded. Patients with multiple myeloma will be allowed.

- Patients requiring radiation therapy between the diaphragm and pelvis 4 weeks prior to
Visit 1 (screening) and/or during Part A of the study are excluded. Any patients with
suspected clinically relevant radiation-induced injury of small or large intestine are
excluded.

- Pregnancy or lactation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2012
Sample size
Target
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Broadmeadow
Recruitment hospital [2] 0 0
Research Site - Frankston
Recruitment hospital [3] 0 0
Research Site - Malvern
Recruitment hospital [4] 0 0
Research Site - Parkville
Recruitment hospital [5] 0 0
Research Site - Fremantle
Recruitment postcode(s) [1] 0 0
- Broadmeadow
Recruitment postcode(s) [2] 0 0
- Frankston
Recruitment postcode(s) [3] 0 0
- Malvern
Recruitment postcode(s) [4] 0 0
- Parkville
Recruitment postcode(s) [5] 0 0
- Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Hawaii
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Mississippi
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Montana
Country [19] 0 0
United States of America
State/province [19] 0 0
Nebraska
Country [20] 0 0
United States of America
State/province [20] 0 0
Nevada
Country [21] 0 0
United States of America
State/province [21] 0 0
New Jersey
Country [22] 0 0
United States of America
State/province [22] 0 0
New York
Country [23] 0 0
United States of America
State/province [23] 0 0
North Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
North Dakota
Country [25] 0 0
United States of America
State/province [25] 0 0
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
Rhode Island
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
Tennessee
Country [30] 0 0
United States of America
State/province [30] 0 0
Texas
Country [31] 0 0
United States of America
State/province [31] 0 0
Virginia
Country [32] 0 0
Belgium
State/province [32] 0 0
Brussels
Country [33] 0 0
Belgium
State/province [33] 0 0
Edegem
Country [34] 0 0
Belgium
State/province [34] 0 0
Mons
Country [35] 0 0
Belgium
State/province [35] 0 0
Wetteren
Country [36] 0 0
Bulgaria
State/province [36] 0 0
Haskovo
Country [37] 0 0
Bulgaria
State/province [37] 0 0
Pleven
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Ruse
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Shumen
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Sofia
Country [41] 0 0
Bulgaria
State/province [41] 0 0
Varna
Country [42] 0 0
Croatia
State/province [42] 0 0
Zagreb
Country [43] 0 0
Czech Republic
State/province [43] 0 0
Benesov
Country [44] 0 0
Czech Republic
State/province [44] 0 0
Ceske Budejovice
Country [45] 0 0
Czech Republic
State/province [45] 0 0
Praha 2
Country [46] 0 0
Germany
State/province [46] 0 0
BE
Country [47] 0 0
Germany
State/province [47] 0 0
HE
Country [48] 0 0
Germany
State/province [48] 0 0
HH
Country [49] 0 0
Germany
State/province [49] 0 0
Offenbach
Country [50] 0 0
Poland
State/province [50] 0 0
Brzozow
Country [51] 0 0
Poland
State/province [51] 0 0
Bydgoszcz
Country [52] 0 0
Poland
State/province [52] 0 0
Gdansk
Country [53] 0 0
Poland
State/province [53] 0 0
Gliwice
Country [54] 0 0
Poland
State/province [54] 0 0
Poznan
Country [55] 0 0
Poland
State/province [55] 0 0
Warsaw
Country [56] 0 0
Poland
State/province [56] 0 0
Wroclaw
Country [57] 0 0
Puerto Rico
State/province [57] 0 0
Ponce
Country [58] 0 0
Romania
State/province [58] 0 0
Dolj
Country [59] 0 0
Romania
State/province [59] 0 0
Prahova
Country [60] 0 0
Romania
State/province [60] 0 0
Baia Mare
Country [61] 0 0
Romania
State/province [61] 0 0
Braila
Country [62] 0 0
Romania
State/province [62] 0 0
Brasov
Country [63] 0 0
Romania
State/province [63] 0 0
Bucuresti
Country [64] 0 0
Romania
State/province [64] 0 0
Cluj-napoca
Country [65] 0 0
Romania
State/province [65] 0 0
Onesti
Country [66] 0 0
Slovakia
State/province [66] 0 0
Bardejov
Country [67] 0 0
Slovakia
State/province [67] 0 0
Bratislava
Country [68] 0 0
Slovakia
State/province [68] 0 0
Kosice
Country [69] 0 0
Slovakia
State/province [69] 0 0
Presov
Country [70] 0 0
South Africa
State/province [70] 0 0
Eastern Cape
Country [71] 0 0
South Africa
State/province [71] 0 0
Free State
Country [72] 0 0
South Africa
State/province [72] 0 0
Gauteng
Country [73] 0 0
South Africa
State/province [73] 0 0
Kz-natal
Country [74] 0 0
South Africa
State/province [74] 0 0
W Cape
Country [75] 0 0
Spain
State/province [75] 0 0
Andalucia
Country [76] 0 0
Spain
State/province [76] 0 0
Comunidad Valenciana
Country [77] 0 0
Spain
State/province [77] 0 0
Galicia
Country [78] 0 0
United Kingdom
State/province [78] 0 0
CRF
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Norfolk
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Surrey
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Wilts
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Coventry
Country [83] 0 0
United Kingdom
State/province [83] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare the effect of NKTR-118 with placebo in the treatment
of opioid-induced constipation (OIC) in patients with cancer-related pain, including those
patients that have inadequate response to laxative therapy (LIR).

The study consists of 2 parts; A initial 4-week treatment period (part A) and then a 12 week
extension with active treatment (part B).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01384292
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01384292