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

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ClinicalTrials.gov Identifier: NCT02183129
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Diclofenac Drug: Meloxicam Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : April 1999
Actual Primary Completion Date : November 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Meloxicam Drug: Meloxicam
Active Comparator: Diclofenac Drug: Diclofenac



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:


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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183129     History of Changes
Other Study ID Numbers: 107.229
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Diclofenac
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors