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BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis

NCT02230956 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2017-05-31

Study results available
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Summary

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.

Conditions

Interventions

BIOLOGICAL

onabotulinumtoxinA

onabotulinumtoxinA (botulinum toxin Type A) injection into the intra-articular space of the study knee.

DRUG

Normal Saline

Normal Saline (placebo) injection into the intra-articular space of the study knee.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States
  • Czechia
  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02230956 on ClinicalTrials.gov