NCT01518257

Safety and Efficacy Study of Botulinum Toxin Type A as Treatment for Osteoarthritis Knee Pain

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of a single intra-articular (IA) injection of botulinum toxin Type A compared with placebo as treatment for osteoarthritis (OA) knee pain.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	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.
DRUG	Normal Saline	A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2012-01-25
• Last updated: 2014-08-07
• Results posted: 2014-08-07

Locations

1 site across 1 country: Denmark