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NCT02139319 Clinical Trial

Dose-Escalation of Botulinum Toxin in Subjects With Osteoarthritis of the Knee

Knee Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02139319
Other study ID # 43QM1309
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date March 2014
Est. completion date July 2014

Study information
Verified date August 2014
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the safety and tolerability of the drug product at each dose level.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers No
Gender All
Age group 25 Years to 80 Years
Eligibility Inclusion Criteria: - Osteoarthritis of the knee - Fully weight bearing in the index knee with or without the need for assistive/orthopaedic devices - Pain score =40 mm of the index knee - Committing to continue using their assistive/orthopaedic device throughout the study using the same regimen Exclusion Criteria: - Any infection in the index knee or inflammatory skin disease or other inflammatory diseases at the index knee or the anticipated injection site - Surgery on the symptomatic knee within the previous 12 months or arthroscopy in the index knee in the past 3 months - Any painful orthopaedic disorder of the back or hip which is likely to interfere with the safety or efficacy assessments - A joint disorder other than osteoarthritis in the index knee which could potentially interfere with the safety or efficacy assessments

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Botulinum toxin

• Placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Galderma R&D

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence and severity of adverse events Up to 6 weeks
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