Back to resultsEfficacy and Safety of a New Formulation of Chondroitin Sulfate and Glucosamine Sulfate to Treat Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
CS+SG
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility 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.
Sites / Locations
- Complejo Hospitalario Universitario La Coruña
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CS+SG
Placebo
Arm Description
Chondroitin sulfate 1200mg+ glucosamine sulfate 1500mg orally administered once a day for 24 weeks
Placebo of chondroitin sulfate + glucosamine sulfate orally administered once a day for 24 weeks
Outcomes
Primary Outcome Measures
Change in Pain According to VAS (0-100 mm)
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01893905
Brief Title
Efficacy and Safety of a New Formulation of Chondroitin Sulfate and Glucosamine Sulfate to Treat Knee Osteoarthritis
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 Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tedec-Meiji Farma, S.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CS+SG
Arm Type
Experimental
Arm Description
Chondroitin sulfate 1200mg+ glucosamine sulfate 1500mg orally administered once a day for 24 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo of chondroitin sulfate + glucosamine sulfate orally administered once a day for 24 weeks
Intervention Type
Drug
Intervention Name(s)
CS+SG
Other Intervention Name(s)
Chondroitin sulfate+glucosamine sulfate
Intervention Description
Chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo chondroitin sulfate+glucosamine sulfate
Intervention Description
Placebo of chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.
Primary Outcome Measure Information:
Title
Change in Pain According to VAS (0-100 mm)
Description
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).
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FJ Blanco, M.D.
Organizational Affiliation
Complejo Hospitalario Universitario La Coruña
Official's Role
Principal Investigator
Facility Information:
Facility Name
Complejo Hospitalario Universitario La Coruña
City
A Coruña
State/Province
La Coruña
ZIP/Postal Code
15006
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27477804
Citation
Roman-Blas JA, Castaneda S, Sanchez-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.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of a New Formulation of Chondroitin Sulfate and Glucosamine Sulfate to Treat Knee Osteoarthritis
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