Efficacy and Safety of a New Formulation of Chondroitin Sulfate and Glucosamine Sulfate to Treat Knee Osteoarthritis
|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: NCT01893905|
Recruitment Status : Completed
First Posted : July 9, 2013
Results First Posted : August 4, 2017
Last Update Posted : August 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Drug: CS+SG Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||158 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Chondroitin sulfate 1200mg+ glucosamine sulfate 1500mg orally administered once a day for 24 weeks
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
Placebo of chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.
Other Name: Placebo chondroitin sulfate+glucosamine sulfate
- 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).
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
|Complejo Hospitalario Universitario La Coruña|
|A Coruña, La Coruña, Spain, 15006|
|Principal Investigator:||FJ Blanco, M.D.||Complejo Hospitalario Universitario La Coruña|