- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02183116
A Study to Access the Efficacy and Safety of Meloxicam in Patients With Osteoarthritis of the Knee
July 4, 2014 updated by: Boehringer Ingelheim
Open Study to Access the Efficacy and Safety of Meloxicam 7.5mg in Patients With Osteoarthritis of the Knee
To Access the Efficacy and Safety of Meloxicam 7.5mg once daily over a treatment period of 56 days
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
34 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Osteoarthritis of the knee requiring the therapy with non-steroidal anti-inflammatory drugs (NSAIDs)
Exclusion Criteria:
none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Meloxicam
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in pain on active movement assessed by a 100 mm visual analogue scale (100 mm, VAS)
Time Frame: Baseline, 8 weeks after first drug administration
|
Baseline, 8 weeks after first drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in Lequesne index
Time Frame: Baseline, 8 weeks after first drug administration
|
Baseline, 8 weeks after first drug administration
|
Change from baseline in physical examination (tenderness)
Time Frame: Baseline, 8 weeks after first drug administration
|
Baseline, 8 weeks after first drug administration
|
Assessment of significant change from baseline in status according endoscopy
Time Frame: Baseline, 8 weeks after first drug administration
|
Baseline, 8 weeks after first drug administration
|
Assessment of significant change from baseline in gastrointestinal (GI) symptoms score
Time Frame: Baseline, 8 weeks after first drug administration
|
Baseline, 8 weeks after first drug administration
|
Assessment of significant change from baseline in laboratory values
Time Frame: Baseline, 8 weeks after first drug administration
|
Baseline, 8 weeks after first drug administration
|
Number of Patients with Adverse Events
Time Frame: Up to 8 weeks after first drug administration
|
Up to 8 weeks after first drug administration
|
Assessment of significant change from baseline in physical examination (swelling)
Time Frame: Baseline, 8 weeks after treatment
|
Baseline, 8 weeks after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 1998
Primary Completion (Actual)
February 1, 1999
Study Registration Dates
First Submitted
July 4, 2014
First Submitted That Met QC Criteria
July 4, 2014
First Posted (Estimate)
July 8, 2014
Study Record Updates
Last Update Posted (Estimate)
July 8, 2014
Last Update Submitted That Met QC Criteria
July 4, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Osteoarthritis, Knee
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Meloxicam
Other Study ID Numbers
- 107.228
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoarthritis
-
Sanford HealthActive, not recruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder Osteoarthritis | Ankle Osteoarthritis | Wrist OsteoarthritisUnited States
-
University of EdinburghHospital for Special Surgery, New YorkRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited Kingdom
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
University of California, San FranciscoStanford University; Robert Wood Johnson FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
University of VermontCompletedOsteoarthritis of Knee | Osteoarthritis Of HipUnited States
-
Hospital for Special Surgery, New YorkRoyal Infirmary of EdinburghRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited States, United Kingdom
-
Ottawa Hospital Research InstituteNot yet recruitingKnee Osteoarthritis | Hip Osteoarthritis
-
University Hospital, LilleCompleted
-
Massachusetts General HospitalNewton-Wellesley Hospital; The New England Baptist HospitalCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
Clinical Trials on Meloxicam
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted