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BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis
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.
Details
| Lead sponsor | Allergan |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 176 |
| Start date | 2014-10 |
| Completion | 2016-03 |
Conditions
- Osteoarthritis
Interventions
- onabotulinumtoxinA
- Normal Saline
Primary outcomes
- Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale — Baseline, Week 8
Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.
Countries
United States, Czechia, Denmark