Back to resultsStudy to Assess the Efficacy and Safety of Meloxicam vs. Diclofenac SR in Patients With Osteoarthritis of the Knee
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Diclofenac
Meloxicam
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Osteoarthritis of the knee requiring the therapy with non-steroidal anti-inflammatory drugs (NSAIDs)
Exclusion Criteria:
none
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Meloxicam
Diclofenac
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in pain on active movement assessed by a 100 mm visual analogue Scale (VAS)
Secondary Outcome Measures
Change from baseline in Lequesne index
Change from baseline in global assessment by the patient and doctor on a 3-point scale
Number of patients with significant changes from baseline in Laboratory values
Number of patients with significant changes from baseline in physical examinations
Number of patients with Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02183129
Brief Title
Study to Assess the Efficacy and Safety of Meloxicam vs. Diclofenac SR in Patients With Osteoarthritis of the Knee
Official Title
Open Label Study to Assess the Efficacy and Safety of Meloxicam 7.5mg vs. Diclofenac 100mg SR in Patients With Osteoarthritis of the Knee
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
November 1999 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
To assess the efficacy and safety of meloxicam 7.5mg once daily compared with diclofenac 100mg SR once daily over a treatment period of 8 weeks
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meloxicam
Arm Type
Experimental
Arm Title
Diclofenac
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Intervention Type
Drug
Intervention Name(s)
Meloxicam
Primary Outcome Measure Information:
Title
Change from baseline in pain on active movement assessed by a 100 mm visual analogue Scale (VAS)
Time Frame
Baseline, 8 weeks after first drug administration
Secondary Outcome Measure Information:
Title
Change from baseline in Lequesne index
Time Frame
Baseline, 8 weeks after first drug administration
Title
Change from baseline in global assessment by the patient and doctor on a 3-point scale
Time Frame
Baseline, 8 weeks after first drug administration
Title
Number of patients with significant changes from baseline in Laboratory values
Time Frame
Baseline, 8 weeks after first drug administration
Title
Number of patients with significant changes from baseline in physical examinations
Time Frame
Baseline, 8 weeks after first drug administration
Title
Number of patients with Adverse Events
Time Frame
Up to 8 weeks after first drug administration
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Osteoarthritis of the knee requiring the therapy with non-steroidal anti-inflammatory drugs (NSAIDs)
Exclusion Criteria:
none
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/107/107.229_U00-0096.pdf
Description
Related Info
Learn more about this trial
Study to Assess the Efficacy and Safety of Meloxicam vs. Diclofenac SR in Patients With Osteoarthritis of the Knee
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