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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


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 (WOMACâ„¢) Pain Score Using an 11-Point Scale Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24 No
Secondary Change from Baseline in the WOMACâ„¢ 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
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