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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02139319
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : August 5, 2014
Sponsor:
Information provided by (Responsible Party):
Q-Med AB

Study Description
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Brief Summary:
The purpose of the study is to evaluate the safety and tolerability of the drug product at each dose level.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Botulinum toxin Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Botulinum toxin
Single intra-articular injection
 Drug: Botulinum toxin
Placebo Comparator: Placebo
Single intra-articular injection
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and severity of adverse events [ Time Frame: Up to 6 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139319


Locations
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United Kingdom
London, United Kingdom
Sponsors and Collaborators
Q-Med AB
Investigators
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Study Director: Q-Med AB Q-Med AB
More Information
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Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT02139319    
Other Study ID Numbers: 43QM1309
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: August 5, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Botulinum Toxins
 Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs