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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
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United States of America
State/province [3] 0 0
Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Idaho
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United States of America
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Illinois
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Indiana
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Kansas
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Maryland
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Massachusetts
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Michigan
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Missouri
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Nebraska
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Nevada
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New Jersey
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New York
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North Carolina
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Oklahoma
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Pennsylvania
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Rhode Island
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South Carolina
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Texas
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Virginia
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Washington
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Argentina
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Buenos Aires
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Argentina
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Rosario
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Belgium
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Bruxelles
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Belgium
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Leuven
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Brazil
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Goiânia GO
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Brazil
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Porto Alegre RS
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Brazil
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São Paulo - SP
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British Columbia
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Ontario
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Marseille
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Tours
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Aachen
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Germany
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Bad Kreuznach
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Germany
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Bad Segeberg
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Berlin
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Ellefeld
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Essen
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Klotten
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Leipzig
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München
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Nürnberg
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Steinhöring
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Germany
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Tübingen
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Germany
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Wiesbaden
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Hungary
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Budapest
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Hungary
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Debrecen
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Györ
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Hévíz
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Miskolc
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Pecs
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Szeged
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Veszprem
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Hungary
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Ózd
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Italy
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Genova
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Italy
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Jesi
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Italy
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Napoli
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Italy
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SAN CESARIO (Lecce)
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Korea, Republic of
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Gyeonggi-Do
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Korea, Republic of
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Seoul
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Russian Federation
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Moscow
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Taiwan
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Kaohsiung
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Taipei
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Ukraine
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Dnyepropetrovsk
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Ukraine
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Donetsk
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Kharkov
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Kiev
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Ukraine
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Kyiv

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

Ethics approval
Ethics application status

Summary
Brief summary
A 12-week trial consisting of 5 visits (6 if follow up is needed) to find out how effective and safe three different doses of meloxicam are compared with placebo in Rheumatoid Arthritis. Patient will take one dose of study medication daily.
Trial website
https://clinicaltrials.gov/study/NCT00042068
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00042068