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Efficacy and Safety of a New Formulation of Chondroitin Sulfate and Glucosamine Sulfate to Treat Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT01893905
Recruitment Status : Completed
First Posted : July 9, 2013
Results First Posted : August 4, 2017
Last Update Posted : August 4, 2017
Sponsor:
Information provided by (Responsible Party):
Tedec-Meiji Farma, S.A.

Tracking Information
First Submitted Date  ICMJE July 2, 2013
First Posted Date  ICMJE July 9, 2013
Results First Submitted Date  ICMJE December 22, 2016
Results First Posted Date  ICMJE August 4, 2017
Last Update Posted Date August 4, 2017
Study Start Date  ICMJE June 2013
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2017)
Change in Pain According to VAS (0-100 mm) [ Time Frame: 24 weeks ]
VAS=The visual analogue scale is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, the patients specify their condition by indicating a position along a continuous line between two end-points. In our case a 0-100 mm line was used to define the degree of pain. The change between baseline and each evaluation visit (week 4, week 12 and week 24) was calculated to evaluate the efficacy of the treatments (a negative number represents a decrease in pain).
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2013)
Reduction of pain using VAS [ Time Frame: 24 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2013)
  • OMERACT-OARSI responder criteria [ Time Frame: 24 weeks ]
  • WOMAC Index (pain, stiffness and function) [ Time Frame: 24 weeks ]
  • Investigator global assessment [ Time Frame: 24 weeks ]
  • Patient global assessment [ Time Frame: 24 weeks ]
  • Consumption of rescue medication [ Time Frame: 24 weeks ]
  • Adverse events recording [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of a New Formulation of Chondroitin Sulfate and Glucosamine Sulfate to Treat Knee Osteoarthritis
Official Title  ICMJE Phase III Clinical Trial to Evaluate the Efficacy and Safety of Chondroitin Sulfate and Glucosamine Sulfate in Combination Versus Placebo in Patients With Osteoarthritis of the Knee
Brief Summary The main objective is to assess the efficacy of a new formulation containing chondroitin sulfate and glucosamine sulfate (CS+GS) compared with placebo in patients with primary osteoarthritis of the knee.
Detailed Description The purpose of this study is to determine whether a new combination of chondroitin sulfate and glucosamine sulfate administered once a day is superior to placebo in the treatment of patients with moderate to severe knee osteoarthritis. Eligible patients will be randomized 1:1 and the treatments will be administered for 24 weeks. Clinical efficacy at the end of treatment will be evaluated. Safety will be evaluated through adverse events recoding during the study period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • Drug: CS+SG
    Chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.
    Other Name: Chondroitin sulfate+glucosamine sulfate
  • Drug: Placebo
    Placebo of chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.
    Other Name: Placebo chondroitin sulfate+glucosamine sulfate
Study Arms  ICMJE
  • Experimental: CS+SG
    Chondroitin sulfate 1200mg+ glucosamine sulfate 1500mg orally administered once a day for 24 weeks
    Intervention: Drug: CS+SG
  • Placebo Comparator: Placebo
    Placebo of chondroitin sulfate + glucosamine sulfate orally administered once a day for 24 weeks
    Intervention: Drug: Placebo
Publications * Roman-Blas JA, Castañeda S, Sánchez-Pernaute O, Largo R, Herrero-Beaumont G; CS/GS Combined Therapy Study Group. Combined Treatment With Chondroitin Sulfate and Glucosamine Sulfate Shows No Superiority Over Placebo for Reduction of Joint Pain and Functional Impairment in Patients With Knee Osteoarthritis: A Six-Month Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Arthritis Rheumatol. 2017 Jan;69(1):77-85. doi: 10.1002/art.39819. Erratum in: Arthritis Rheumatol. 2017 Oct;69(10 ):2080.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2017)
158
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2013)
314
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient >= 45 years .
  • Primary OA of the knee according to ACR criteria.
  • OA radiological grade II-III according to Kellgren and Lawrence.
  • Patients with moderate-severe pain.

Exclusion Criteria:

  • Patients with clinical significant trauma or surgery in the target knee.
  • Concurrent arthritic disease (antecedents and/or current signs) that could confound or interfere with the evaluation of pain efficacy such as chondrocalcinosis, Paget's disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, Wilson's disease, osteochondromatosis, seronegative spondyloarthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease or fibromyalgia.
  • Pain in other parts of the body greater than the knee pain that could interfere with the evaluation.
  • Subjects with any active acute or chronic infections requiring antimicrobial therapy, or serious viral (e.g., hepatitis, herpes zoster, HIV positivity) or fungal infections.
  • Clinical diagnosis established of uncontrolled diabetes mellitus.
  • Patients with asthma.
  • History of hypersensitivity to the active drugs or any excipients of the formulations.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01893905
Other Study ID Numbers  ICMJE TM-CS+SG /301
2013-000444-26 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tedec-Meiji Farma, S.A.
Study Sponsor  ICMJE Tedec-Meiji Farma, S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: FJ Blanco, M.D. Complejo Hospitalario Universitario La Coruña
PRS Account Tedec-Meiji Farma, S.A.
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP