Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Montgomery, Alabama 36106


Purpose:

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.


Criteria:

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 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 is Available At:


Original ID:

107.258


NCT ID:

NCT00042068


Secondary ID:


Study Acronym:


Brief Title:

A Multi-Center Trial to Compare Three Doses of Meloxicam and Placebo in Patients With Rheumatoid Arthritis


Official 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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Boehringer Ingelheim Pharmaceuticals


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Parall


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

1000


Enrollment Type:


Overall Contact Information

Official Name:Boehringer Ingelheim Study Coordinator
Study Chair
Boehringer Ingelheim Ltd./Bracknell

Study Dates

Start Date:June 2002
Completion Date:July 2003
Verification Date:October 2013
Last Changed Date:October 31, 2013
First Received Date:July 22, 2002

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Withdrawals due to adverse events
Time Frame:at end of 12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Investigator's final global assessment of tolerability
Time Frame:at end of 12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Patient's final global assessment of tolerability
Time Frame:at end of 12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Incidence and intensity of adverse events
Time Frame:until 4 weeks post treatment
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Use of rescue medication
Time Frame:up to 12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Patient status with regard to change in arthritic condition
Time Frame:at end of 12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Investigator's final global (overall) assessment of efficacy
Time Frame:at end of 12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Patient's final global (overall) assessment of efficacy
Time Frame:at end of 12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Duration of morning stiffness
Time Frame:up to of 12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Withdrawal due to lack of efficacy
Time Frame:up to 12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:C-Reactive Protein (CRP)
Time Frame:up to 12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Patient's assessment of physical function (mHAQ)
Time Frame:up to 12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Patient's assessment of pain
Time Frame:up to 12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Investigator's global (overall) assessment of disease activity
Time Frame:up to 12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Patient's global (overall) assessment of disease activity
Time Frame:up to 12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Number of swollen joints
Time Frame:up to 12 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Number of painful or tender joints
Time Frame:up to 12 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Response according to American College of Rheumatology 20% (ACR20) classification
Time Frame:at 12 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Meloxicam

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Boehringer Ingelheim Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.