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

July 4, 2014 updated by: Boehringer Ingelheim

Open Label Study to Assess the Efficacy and Safety of Meloxicam 7.5mg vs. Diclofenac 100mg SR in Patients With Osteoarthritis of the Knee

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

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

  • Child
  • 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Diclofenac
Drug: Diclofenac
Experimental: Meloxicam
Drug: Meloxicam

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 (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 global assessment by the patient and doctor on a 3-point scale
Time Frame: Baseline, 8 weeks after first drug administration
Baseline, 8 weeks after first drug administration
Number of patients with significant changes 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 significant changes from baseline in physical examinations
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

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

April 1, 1999

Primary Completion (Actual)

November 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

Other Study ID Numbers

  • 107.229

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.

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