BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis

May 5, 2017 updated by: Allergan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OnabotulinumtoxinA 400 U
OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
Biological: onabotulinumtoxinA
onabotulinumtoxinA (botulinum toxin Type A) injection into the intra-articular space of the study knee.
Other Names:
  • BOTOX®
  • botulinum toxin Type A
Experimental: OnabotulinumtoxinA 200 U
OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
Biological: onabotulinumtoxinA
onabotulinumtoxinA (botulinum toxin Type A) injection into the intra-articular space of the study knee.
Other Names:
  • BOTOX®
  • botulinum toxin Type A
Placebo Comparator: Placebo
Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
Drug: Normal Saline
Normal Saline (placebo) injection into the intra-articular space of the study knee.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale
Time Frame: 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.
Baseline, Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale
Time Frame: Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24
The WOMAC Pain Score consisted of 5 questions about pain completed by the participant where: 0=no pain to 10=extreme pain for a total possible Pain Score of 0 (best) to 50 (worst). A negative change from Baseline indicates improvement.
Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24
Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale
Time Frame: Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24
The WOMAC Physical Function Score consisted of 17 questions about the difficulty of daily activities completed by the participant where: 0=no difficulty to 10=extreme difficulty for a total possible Physical Function Score of 0 (best) to 170 (worst). A negative change from Baseline indicates improvement.
Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24
Patient Global Impression of Change (GIC) Using a 7-Point Scale
Time Frame: Weeks 1, 4, 8, 12, 16, 20 and 24
The participant rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicate worsening and positive scores indicate improvement.
Weeks 1, 4, 8, 12, 16, 20 and 24
Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale
Time Frame: Baseline, Week 24
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 worst pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.
Baseline, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

August 29, 2014

First Submitted That Met QC Criteria

August 29, 2014

First Posted (Estimate)

September 3, 2014

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 5, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191622-145
  • 2014-001076-58 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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