Safety and Efficacy Study of Botulinum Toxin Type A as Treatment for Osteoarthritis Knee Pain
NCT ID: NCT01518257
Last Updated: 2014-08-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
121 participants
INTERVENTIONAL
2012-01-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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botulinum toxin Type A
A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
botulinum toxin Type A
A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
Placebo
A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
Normal Saline
A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
Interventions
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botulinum toxin Type A
A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
Normal Saline
A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to walk without assistive walking devices, able to perform usual daily activities, and agree to maintain similar activity level throughout the study
Exclusion Criteria
* Presence of bursitis, meniscus tear, ligament tear, or significant injury to the study knee within 1 year
* Surgery to the study knee within 24 weeks
* Treatment with hyaluronic acid in the study knee within 24 weeks
* Treatment with corticosteroids in the study knee within 12 weeks
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
* Previous treatment with botulinum toxin of any serotype for any reason
40 Years
75 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Aalborg, , Denmark
Countries
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Other Identifiers
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191622-102
Identifier Type: -
Identifier Source: org_study_id
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