Status:
COMPLETED
Efficacy and Safety of Topical Diclofenac Combined With Oral Diclofenac in the Treatment of Knee Osteoarthritis
Lead Sponsor:
Nuvo Research Inc.
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
40-85 years
Phase:
PHASE3
Brief Summary
Oral non-steroidal anti-inflammatory drugs (NSAIDs) are a recommended treatment for the symptoms of osteoarthritis of the knee. However, NSAIDs may cause a range of negative side effects, including st...
Detailed Description
During this 12-week study, patients will visit the study clinic 5 times. At the screening visit, the patient's demographic information, medical and medication history will be recorded and a physical e...
Eligibility Criteria
Inclusion
- Primary osteoarthritis of the knee, verified radiographically
- Moderate flare of pain in the knee after washout of stable therapy
- If female, non-pregnant
- Ability to swallow moderately-sized tablets
Exclusion
- Secondary osteoarthritis of the knee
- Major knee surgery at any time, or minor knee surgery in previous year
- Severe uncontrolled heart, liver or kidney disease
- Ulcer or bleeding from the stomach
- Corticosteroid use
- Fibromyalgia
- Skin disorder of the knee
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT00108992
Start Date
February 1 2004
End Date
September 1 2005
Last Update
January 5 2007
Active Locations (22)
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1
Coastal Clinical Research
Mobile, Alabama, United States, 36608
2
Redpoint Research
Phoenix, Arizona, United States, 85029
3
OMC Clinical
Beverly Hills, California, United States, 90211
4
Associated Pharmaceutical Research
Buena Park, California, United States, 90620