A Study to Access the Efficacy and Safety of Meloxicam in Patients With Osteoarthritis of the Knee

Phase 4

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Meloxicam

• Registration Number: NCT02183116
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To Access the Efficacy and Safety of Meloxicam 7.5mg once daily over a treatment period of 56 days

Detailed Description

Not available

Study Timeline

• Study Start: 1998-10
• Primary Completion: 1999-02
• Status Verified: 2014-07
• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-04
• Last Update Submitted: 2014-07-04
• Study First Posted: 2014-07-08
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Meloxicam	Meloxicam	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Lequesne index	Baseline, 8 weeks after first drug administration
Change from baseline in physical examination (tenderness)	Baseline, 8 weeks after first drug administration
Assessment of significant change from baseline in status according endoscopy	Baseline, 8 weeks after first drug administration
Assessment of significant change from baseline in gastrointestinal (GI) symptoms score	Baseline, 8 weeks after first drug administration
Assessment of significant change from baseline in laboratory values	Baseline, 8 weeks after first drug administration
Number of Patients with Adverse Events	Up to 8 weeks after first drug administration
Assessment of significant change from baseline in physical examination (swelling)	Baseline, 8 weeks after treatment