Osteoarthritis Clinical Trial
Verified date | July 2016 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study will evaluate the efficacy and safety of a single intra-articular injection of 2 doses of BOTOX® (onabotulinumtoxinA) compared with placebo as treatment for knee osteoarthritis symptoms.
Status | Completed |
Enrollment | 176 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Painful osteoarthritis - Able to discontinue anti-inflammatory drugs and analgesics - Must be ambulatory without assistive walking devices Exclusion Criteria: - Chronic pain conditions other than knee osteoarthritis - Treatment with corticosteroids in the study knee within 12 weeks - Treatment with hyaluronic acid in the study knee within 24 weeks - Previous treatment with any botulinum toxin for any reason - Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Allergan |
United States, Czech Republic, Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale | Baseline, Week 8 | No | |
Secondary | Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMACâ„¢) Pain Score Using an 11-Point Scale | Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24 | No | |
Secondary | Change from Baseline in the WOMACâ„¢ Physical Function Score Using an 11-Point Scale | Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24 | No | |
Secondary | Patient Global Impression of Change (GIC) Using a 7-Point Scale | Weeks 1, 4, 8, 12, 16, 20 and 24 | No | |
Secondary | Change from Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale | Baseline, 24 Weeks | No |
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