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OpenTrials
Completed

NCT Number: NCT02183129

Study to Assess the Efficacy and Safety of Meloxicam vs. Diclofenac 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

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Diclofenac

Drug

Meloxicam

Drug

Primary outcomes

  1. 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 outcomes

  1. Change from baseline in Lequesne index

    Time frame: Baseline, 8 weeks after first drug administration

  2. 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

  3. Number of patients with significant changes from baseline in Laboratory values

    Time frame: Baseline, 8 weeks after first drug administration

  4. Number of patients with significant changes from baseline in physical examinations

    Time frame: Baseline, 8 weeks after first drug administration

  5. Number of patients with Adverse Events

    Time frame: Up to 8 weeks after first drug administration

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
1999
Primary completion
1999
First posted
Jul 8, 2014
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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