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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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Knee Osteoarthritis
Interventions Drug: CS+SG
Drug: Placebo
Enrollment 158
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CS+SG Placebo
Hide Arm/Group Description Chondroitin sulfate+ glucosamine sulfate Oral Placebo
Period Title: Overall Study
Started 80 78
Completed 55 64
Not Completed 25 14
Reason Not Completed
Withdrawal by Subject             1             0
Adverse Event             9             3
Lack of Efficacy             5             7
Lost to Follow-up             1             0
Protocol Violation             6             1
Lack of adherence to treatment             2             0
Other reason             1             3
Arm/Group Title CS+SG Placebo Total
Hide Arm/Group Description Chondroitin sulfate+glucosamine sulfate Placebo oral Total of all reporting groups
Overall Number of Baseline Participants 80 78 158
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants 78 participants 158 participants
65.49  (8.17) 67.60  (8.90) 66.53  (8.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 78 participants 158 participants
Female
65
  81.3%
67
  85.9%
132
  83.5%
Male
15
  18.8%
11
  14.1%
26
  16.5%
1.Primary Outcome
Title Change in Pain According to VAS (0-100 mm)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CS+SG Placebo
Hide Arm/Group Description:
Chondroitin sulfate+glucosamine sulfate
Placebo Oral
Overall Number of Participants Analyzed 80 78
Mean (Standard Deviation)
Unit of Measure: units on a scale
-11.86  (2.42) -20.57  (2.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0307
Comments [Not Specified]
Method Pocock approach
Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CS+SG Placebo
Hide Arm/Group Description chondroitin sulfate+glucosamine sulfate Placebo oral
All-Cause Mortality
CS+SG Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
CS+SG Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/80 (2.50%)      2/78 (2.56%)    
Infections and infestations     
Diverticulitis * 1  1/80 (1.25%)  1 0/78 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer metastatic * 1  1/80 (1.25%)  1 0/78 (0.00%)  0
Breast cancer * 1  0/80 (0.00%)  0 1/78 (1.28%)  1
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism * 1  0/80 (0.00%)  0 1/78 (1.28%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CS+SG Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/80 (25.00%)      18/78 (23.08%)    
Gastrointestinal disorders     
Flatulence  1  4/80 (5.00%)  4 1/78 (1.28%)  1
Infections and infestations     
Nasopharyngitis  1  1/80 (1.25%)  1 6/78 (7.69%)  6
Injury, poisoning and procedural complications     
Injury  1  4/80 (5.00%)  4 0/78 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  1  7/80 (8.75%)  7 4/78 (5.13%)  4
Pain in extremity  1  4/80 (5.00%)  4 3/78 (3.85%)  3
Neck pain  1  2/80 (2.50%)  2 4/78 (5.13%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Francisco Blanco, study coordinator
Organization: Complejo Hospitalario de La Coruña (CHUAC)
Phone: 981 17 80 00
EMail: fblagar@sergas.es
Layout table for additonal information
Responsible Party: Tedec-Meiji Farma, S.A.
ClinicalTrials.gov Identifier: NCT01893905    
Other Study ID Numbers: TM-CS+SG /301
2013-000444-26 ( EudraCT Number )
First Submitted: July 2, 2013
First Posted: July 9, 2013
Results First Submitted: December 22, 2016
Results First Posted: August 4, 2017
Last Update Posted: August 4, 2017