Study to Assess the Efficacy and Safety of Meloxicam vs. Diclofenac SR in Patients With Osteoarthritis of the Knee

Phase 4

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Meloxicam; Drug: Diclofenac

• Registration Number: NCT02183129
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study Start: 1999-04-01
• Primary Completion: 1999-11-01
• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-04
• Study First Posted: 2014-07-08
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• Osteoarthritis of the knee requiring the therapy with non-steroidal anti-inflammatory drugs (NSAIDs)

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Meloxicam	Meloxicam	-
Diclofenac	Diclofenac	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in pain on active movement assessed by a 100 mm visual analogue Scale (VAS)	Baseline, 8 weeks after first drug administration

Secondary Outcome Measures

Name	Time	Method
Number of patients with Adverse Events	Up to 8 weeks after first drug administration
Number of patients with significant changes from baseline in physical examinations	Baseline, 8 weeks after first drug administration
Change from baseline in Lequesne index	Baseline, 8 weeks after first drug administration
Number of patients with significant changes from baseline in Laboratory values	Baseline, 8 weeks after first drug administration
Change from baseline in global assessment by the patient and doctor on a 3-point scale	Baseline, 8 weeks after first drug administration