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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Botulinum toxin

Single intra-articular injection

Group Type EXPERIMENTAL

Botulinum toxin

Intervention Type DRUG

Placebo

Single intra-articular injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Botulinum toxin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No