BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis

Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02230956
• Other study ID #: 191622-145
• Secondary ID: 2014-001076-58
• Status: Completed
• Phase: Phase 2
• First received: August 29, 2014
• Last updated: July 11, 2016
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: July 2016
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Czech Republic,  Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale		Baseline, Week 8	No
Secondary	Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale		Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24	No
Secondary	Change from Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale		Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24	No
Secondary	Patient Global Impression of Change (GIC) Using a 7-Point Scale		Weeks 1, 4, 8, 12, 16, 20 and 24	No
Secondary	Change from Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale		Baseline, 24 Weeks	No

External Links

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