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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.

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: CS+SG Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014


Arm Intervention/treatment
Experimental: CS+SG
Chondroitin sulfate 1200mg+ glucosamine sulfate 1500mg orally administered once a day for 24 weeks
Drug: CS+SG
Chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.
Other Name: Chondroitin sulfate+glucosamine sulfate

Placebo Comparator: Placebo
Placebo of chondroitin sulfate + glucosamine sulfate orally administered once a day for 24 weeks
Drug: Placebo
Placebo of chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.
Other Name: Placebo chondroitin sulfate+glucosamine sulfate




Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT01893905


Locations
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Spain
Complejo Hospitalario Universitario La Coruña
A Coruña, La Coruña, Spain, 15006
Sponsors and Collaborators
Tedec-Meiji Farma, S.A.
Investigators
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Principal Investigator: FJ Blanco, M.D. Complejo Hospitalario Universitario La Coruña

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tedec-Meiji Farma, S.A.
ClinicalTrials.gov Identifier: NCT01893905     History of Changes
Other Study ID Numbers: TM-CS+SG /301
2013-000444-26 ( EudraCT Number )
First Posted: July 9, 2013    Key Record Dates
Results First Posted: August 4, 2017
Last Update Posted: August 4, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases