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

Overview

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

Full Title of Study: “Open Study to Access the Efficacy and Safety of Meloxicam 7.5mg in Patients With Osteoarthritis of the Knee”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 1999

Interventions

  • Drug: Meloxicam

Arms, Groups and Cohorts

  • Experimental: Meloxicam

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Change from baseline in Lequesne index
    • Time Frame: Baseline, 8 weeks after first drug administration
  • Change from baseline in physical examination (tenderness)
    • Time Frame: 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
  • Assessment of significant change from baseline in gastrointestinal (GI) symptoms score
    • Time Frame: 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
  • Number of Patients with Adverse Events
    • Time Frame: 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

Participating in This Clinical Trial

Inclusion Criteria

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

Exclusion Criteria

none

Gender Eligibility: All

Minimum Age: 34 Years

Maximum Age: 74 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Sponsor

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