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Trial record 1 of 1 for:    NCT02230956
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BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02230956
Recruitment Status : Completed
First Posted : September 3, 2014
Results First Posted : April 20, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Biological: onabotulinumtoxinA Drug: Normal Saline Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis
Study Start Date : October 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Osteoarthritis

Arm Intervention/treatment
Experimental: OnabotulinumtoxinA 400 U
OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
Biological: onabotulinumtoxinA
onabotulinumtoxinA (botulinum toxin Type A) injection into the intra-articular space of the study knee.
Other Names:
  • botulinum toxin Type A
  • BOTOX®

Experimental: OnabotulinumtoxinA 200 U
OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
Biological: onabotulinumtoxinA
onabotulinumtoxinA (botulinum toxin Type A) injection into the intra-articular space of the study knee.
Other Names:
  • botulinum toxin Type A
  • BOTOX®

Placebo Comparator: Placebo
Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
Drug: Normal Saline
Normal Saline (placebo) injection into the intra-articular space of the study knee.




Primary Outcome Measures :
  1. Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale [ Time Frame: Baseline, Week 8 ]
    Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.


Secondary Outcome Measures :
  1. Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale [ Time Frame: Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24 ]
    The WOMAC Pain Score consisted of 5 questions about pain completed by the participant where: 0=no pain to 10=extreme pain for a total possible Pain Score of 0 (best) to 50 (worst). A negative change from Baseline indicates improvement.

  2. Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale [ Time Frame: Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24 ]
    The WOMAC Physical Function Score consisted of 17 questions about the difficulty of daily activities completed by the participant where: 0=no difficulty to 10=extreme difficulty for a total possible Physical Function Score of 0 (best) to 170 (worst). A negative change from Baseline indicates improvement.

  3. Patient Global Impression of Change (GIC) Using a 7-Point Scale [ Time Frame: Weeks 1, 4, 8, 12, 16, 20 and 24 ]
    The participant rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicate worsening and positive scores indicate improvement.

  4. Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale [ Time Frame: Baseline, Week 24 ]
    Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily worst pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02230956


Locations
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United States, California
Artesia, California, United States
Czechia
Pardubice, Czechia
Denmark
Vejle, Denmark
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02230956    
Other Study ID Numbers: 191622-145
2014-001076-58 ( EudraCT Number )
First Posted: September 3, 2014    Key Record Dates
Results First Posted: April 20, 2017
Last Update Posted: May 31, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents