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

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ClinicalTrials.gov Identifier: NCT02183116
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 Access the Efficacy and Safety of Meloxicam 7.5mg once daily over a treatment period of 56 days

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Study to Access the Efficacy and Safety of Meloxicam 7.5mg in Patients With Osteoarthritis of the Knee
Study Start Date : October 1998
Actual Primary Completion Date : February 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Meloxicam

Arm Intervention/treatment
Experimental: Meloxicam Drug: Meloxicam
Other Name: Mobic




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change from baseline in Lequesne index [ Time Frame: Baseline, 8 weeks after first drug administration ]
  2. Change from baseline in physical examination (tenderness) [ Time Frame: Baseline, 8 weeks after first drug administration ]
  3. Assessment of significant change from baseline in status according endoscopy [ Time Frame: Baseline, 8 weeks after first drug administration ]
  4. Assessment of significant change from baseline in gastrointestinal (GI) symptoms score [ Time Frame: Baseline, 8 weeks after first drug administration ]
  5. Assessment of significant change from baseline in laboratory values [ Time Frame: Baseline, 8 weeks after first drug administration ]
  6. Number of Patients with Adverse Events [ Time Frame: Up to 8 weeks after first drug administration ]
  7. Assessment of significant change from baseline in physical examination (swelling) [ Time Frame: Baseline, 8 weeks after treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   34 Years to 74 Years   (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:

none


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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183116    
Other Study ID Numbers: 107.228
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
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 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action