Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00042068




Registration number
NCT00042068
Ethics application status
Date submitted
22/07/2002
Date registered
24/07/2002
Date last updated
1/11/2013

Titles & IDs
Public title
A Multi-Center Trial to Compare Three Doses of Meloxicam and Placebo in Patients With Rheumatoid Arthritis
Scientific title
A Multi-center, Double-Blind, Randomized, Parallel-Group Trial to Compare the Efficacy and Safety of Three Doses of Meloxicam (7.5, 15, and 22.5 mg) and Placebo in Patients With Rheumatoid Arthritis
Secondary ID [1] 0 0
107.258
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Response according to American College of Rheumatology 20% (ACR20) classification
Timepoint [1] 0 0
at 12 weeks
Secondary outcome [1] 0 0
Number of painful or tender joints
Timepoint [1] 0 0
up to 12 weeks
Secondary outcome [2] 0 0
Number of swollen joints
Timepoint [2] 0 0
up to 12 weeks
Secondary outcome [3] 0 0
Patient's global (overall) assessment of disease activity
Timepoint [3] 0 0
up to 12 weeks
Secondary outcome [4] 0 0
Investigator's global (overall) assessment of disease activity
Timepoint [4] 0 0
up to 12 weeks
Secondary outcome [5] 0 0
Patient's assessment of pain
Timepoint [5] 0 0
up to 12 weeks
Secondary outcome [6] 0 0
Patient's assessment of physical function (mHAQ)
Timepoint [6] 0 0
up to 12 weeks
Secondary outcome [7] 0 0
C-Reactive Protein (CRP)
Timepoint [7] 0 0
up to 12 weeks
Secondary outcome [8] 0 0
Withdrawal due to lack of efficacy
Timepoint [8] 0 0
up to 12 weeks
Secondary outcome [9] 0 0
Duration of morning stiffness
Timepoint [9] 0 0
up to of 12 weeks
Secondary outcome [10] 0 0
Patient's final global (overall) assessment of efficacy
Timepoint [10] 0 0
at end of 12 weeks
Secondary outcome [11] 0 0
Investigator's final global (overall) assessment of efficacy
Timepoint [11] 0 0
at end of 12 weeks
Secondary outcome [12] 0 0
Patient status with regard to change in arthritic condition
Timepoint [12] 0 0
at end of 12 weeks
Secondary outcome [13] 0 0
Use of rescue medication
Timepoint [13] 0 0
up to 12 weeks
Secondary outcome [14] 0 0
Incidence and intensity of adverse events
Timepoint [14] 0 0
until 4 weeks post treatment
Secondary outcome [15] 0 0
Patient's final global assessment of tolerability
Timepoint [15] 0 0
at end of 12 weeks
Secondary outcome [16] 0 0
Investigator's final global assessment of tolerability
Timepoint [16] 0 0
at end of 12 weeks
Secondary outcome [17] 0 0
Withdrawals due to adverse events
Timepoint [17] 0 0
at end of 12 weeks

Eligibility
Key inclusion criteria
* Age greater than or equal to 18 and less than or equal to 80
* Diagnosis of Rheumatoid Arthritis for at least six weeks
* Taking an NSAID
* If female: using adequate contraception
* Willingness to stop current NSAID until criteria reached to begin study drug
* Able to provide written informed consent
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Intolerance or hypersensitivity to NSAIDs or ingredients of trial drug
* Pregnancy, lactating
* Use of investigational drug within 30 days prior to entering the trial
* History of peptic ulcer or of gastrointestinal hemorrhage except simple hemorrhoidal bleeding
* History of cerebrovascular or other bleeding disorder
* Severe hypertension
* Other disease that might interfere with safety of the patient or evaluation of trial drug (investigator's opinion)
* RA of functional class IV
* Synovectomy in any large joint within the past 6 months prior to entering the trial or planned during trial
* Concomitant therapy with anticoagulant, therapeutic doses of aspirin, phenothiazines, lithium, chronic GI-medication, analgesic drug (except acetaminophen up to 4 grams/day)
* DMARDs initiated within past three months or dose changed less than two months before entering the trial
* Therapy with corticosteroids exceeding 10 mg/day prednisone equivalent or change in dose within 1 month before trial
* Concomitant therapy with ACTH within past month before entering the trial.
* History of narcotic or alcohol abuse (past 12 months)
* Abnormal laboratory values
* Previous participation in the present trial

Study design
Purpose of the study
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?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC,WA
Recruitment hospital [1] 0 0
Boehringer Ingelheim Investigational Site - Cotton Tree
Recruitment hospital [2] 0 0
Emeritus Research - Malvern
Recruitment hospital [3] 0 0
Department of Rheumatology - Perth
Recruitment postcode(s) [1] 0 0
4558 - Cotton Tree
Recruitment postcode(s) [2] 0 0
3144 - Malvern
Recruitment postcode(s) [3] 0 0
6004 - Perth
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
Alaska
Country [3] 0 0
United States of America
State/province [3] 0 0
Arizona
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
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
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
Missouri
Country [17] 0 0
United States of America
State/province [17] 0 0
Nebraska
Country [18] 0 0
United States of America
State/province [18] 0 0
Nevada
Country [19] 0 0
United States of America
State/province [19] 0 0
New Jersey
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Oklahoma
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
Rhode Island
Country [26] 0 0
United States of America
State/province [26] 0 0
South Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Texas
Country [28] 0 0
United States of America
State/province [28] 0 0
Virginia
Country [29] 0 0
United States of America
State/province [29] 0 0
Washington
Country [30] 0 0
Argentina
State/province [30] 0 0
Buenos Aires
Country [31] 0 0
Argentina
State/province [31] 0 0
Rosario
Country [32] 0 0
Belgium
State/province [32] 0 0
Bruxelles
Country [33] 0 0
Belgium
State/province [33] 0 0
Leuven
Country [34] 0 0
Brazil
State/province [34] 0 0
Goiânia GO
Country [35] 0 0
Brazil
State/province [35] 0 0
Porto Alegre RS
Country [36] 0 0
Brazil
State/province [36] 0 0
São Paulo - SP
Country [37] 0 0
Canada
State/province [37] 0 0
British Columbia
Country [38] 0 0
Canada
State/province [38] 0 0
Ontario
Country [39] 0 0
Canada
State/province [39] 0 0
Quebec
Country [40] 0 0
France
State/province [40] 0 0
Marseille
Country [41] 0 0
France
State/province [41] 0 0
Nice
Country [42] 0 0
France
State/province [42] 0 0
Tours cedex 9
Country [43] 0 0
France
State/province [43] 0 0
Tours
Country [44] 0 0
Germany
State/province [44] 0 0
Aachen
Country [45] 0 0
Germany
State/province [45] 0 0
Bad Kreuznach
Country [46] 0 0
Germany
State/province [46] 0 0
Bad Segeberg
Country [47] 0 0
Germany
State/province [47] 0 0
Berlin
Country [48] 0 0
Germany
State/province [48] 0 0
Ellefeld
Country [49] 0 0
Germany
State/province [49] 0 0
Essen
Country [50] 0 0
Germany
State/province [50] 0 0
Klotten
Country [51] 0 0
Germany
State/province [51] 0 0
Leipzig
Country [52] 0 0
Germany
State/province [52] 0 0
München
Country [53] 0 0
Germany
State/province [53] 0 0
Nürnberg
Country [54] 0 0
Germany
State/province [54] 0 0
Steinhöring
Country [55] 0 0
Germany
State/province [55] 0 0
Tübingen
Country [56] 0 0
Germany
State/province [56] 0 0
Wiesbaden
Country [57] 0 0
Hungary
State/province [57] 0 0
Budapest
Country [58] 0 0
Hungary
State/province [58] 0 0
Debrecen
Country [59] 0 0
Hungary
State/province [59] 0 0
Györ
Country [60] 0 0
Hungary
State/province [60] 0 0
Hévíz
Country [61] 0 0
Hungary
State/province [61] 0 0
Miskolc
Country [62] 0 0
Hungary
State/province [62] 0 0
Pecs
Country [63] 0 0
Hungary
State/province [63] 0 0
Szeged
Country [64] 0 0
Hungary
State/province [64] 0 0
Veszprem
Country [65] 0 0
Hungary
State/province [65] 0 0
Ózd
Country [66] 0 0
Italy
State/province [66] 0 0
Genova
Country [67] 0 0
Italy
State/province [67] 0 0
Jesi
Country [68] 0 0
Italy
State/province [68] 0 0
Napoli
Country [69] 0 0
Italy
State/province [69] 0 0
SAN CESARIO (Lecce)
Country [70] 0 0
Korea, Republic of
State/province [70] 0 0
Gyeonggi-Do
Country [71] 0 0
Korea, Republic of
State/province [71] 0 0
Seoul
Country [72] 0 0
Russian Federation
State/province [72] 0 0
Moscow
Country [73] 0 0
Taiwan
State/province [73] 0 0
Kaohsiung
Country [74] 0 0
Taiwan
State/province [74] 0 0
Taipei
Country [75] 0 0
Ukraine
State/province [75] 0 0
Dnyepropetrovsk
Country [76] 0 0
Ukraine
State/province [76] 0 0
Donetsk
Country [77] 0 0
Ukraine
State/province [77] 0 0
Kharkov
Country [78] 0 0
Ukraine
State/province [78] 0 0
Kiev
Country [79] 0 0
Ukraine
State/province [79] 0 0
Kyiv

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim Study Coordinator
Address 0 0
Boehringer Ingelheim Ltd./Bracknell
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00042068