Study of the Effect of Chondroitin Sulfate on Structural Changes in Knee Osteoarthritis Patients Assessed by MRI (MOSAIC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bioiberica
ClinicalTrials.gov Identifier:
NCT01354145
First received: May 13, 2011
Last updated: July 12, 2016
Last verified: July 2016
Results First Received: February 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Knee Osteoarthritis
Interventions: Drug: Chondroitin sulfate
Drug: Celecoxib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Chondroitin Sulfate (Condrosan)

CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning

Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period

Celecoxib (Celebrex)

CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning

Celecoxib: Celecoxib 200 mg/day, 24 months treatment period


Participant Flow:   Overall Study
    Chondroitin Sulfate (Condrosan)     Celecoxib (Celebrex)  
STARTED     97     97  
COMPLETED     58     63  
NOT COMPLETED     39     34  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Chondroitin Sulfate (Condrosan)

CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning

Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period

Celecoxib

CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning

Celecoxib: Celecoxib 200 mg/day, 24 months treatment period

Total Total of all reporting groups

Baseline Measures
    Chondroitin Sulfate (Condrosan)     Celecoxib     Total  
Number of Participants  
[units: participants]
  97     97     194  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     59     56     115  
>=65 years     38     41     79  
Age  
[units: years]
Mean (Standard Deviation)
  61.4  (9.3)     61.3  (8.5)     61.3  (8.9)  
Gender  
[units: participants]
     
Female     44     36     80  
Male     53     61     114  
Cartilage Volume in the Lateral Compartment  
[units: cubic milimeters]
Mean (Standard Deviation)
  6606  (2332)     6343  (1565)     6475  (1985)  
Cartilage Volume in the Medial Compartment  
[units: cubic milimeters]
Mean (Standard Deviation)
  6059  (2031)     5705  (1572)     5882  (1820)  
Cartilage Volume in the Global Knee  
[units: cubic milimeters]
Mean (Standard Deviation)
  12665  (4259)     12048  (2969)     12356  (3674)  



  Outcome Measures
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1.  Primary:   Cartilage Volume Loss of the Lateral Compartment   [ Time Frame: 12 months (Day 364) and 24 months (Day 728) ]

2.  Secondary:   Cartilage Volume Loss of the Global Knee   [ Time Frame: 12 months (Day 364) and 24 months (Day 728) ]

3.  Secondary:   Cartilage Volume in the Medial Compartment   [ Time Frame: 12 months (Day 364) and 24 months (Day 728) ]

4.  Secondary:   Synovial Membrane Thickness   [ Time Frame: Baseline, 12 months (Day 364) and 24 months (Day 728) ]

5.  Secondary:   Bone Marrow Lesions Score   [ Time Frame: Baseline, 12 months (Day 364) and 24 months (Day 728) ]

6.  Secondary:   Synovial Fluid Volume   [ Time Frame: Baseline, 12 months (Day 364) and 24 months (Day 728) ]

7.  Secondary:   Percentage of Participants With the Presence of Extrusion in the Meniscus   [ Time Frame: Baseline, 12 months (Day 364) and 24 months (Day 728) ]

8.  Secondary:   Visual Analog Scale (VAS)   [ Time Frame: Baseline, 12 months (Day 364) and 24 months (Day 728) ]

9.  Secondary:   WOMAC Pain Subscale   [ Time Frame: Baseline, 12 months (Day 364) and 24 months (Day 728) ]

10.  Secondary:   WOMAC Stiffness Subscale   [ Time Frame: Baseline, 12 months (Day 364) and 24 months (Day 728) ]

11.  Secondary:   WOMAC Function Subscale   [ Time Frame: Baseline, 12 months (Day 364) and 24 months (Day 728) ]

12.  Secondary:   Short Form (SF-36) Health Survey   [ Time Frame: Baseline, 12 months (Day 364) and 24 months (Day 728) ]

13.  Secondary:   Percentage of Participants With Presence of Joint Swelling and Effusion   [ Time Frame: Baseline, 12 months (Day 364) and 24 months (Day 728) ]

14.  Secondary:   Use of Acetaminophen   [ Time Frame: 3 months (Day 91), 6 momnths (Day 182), 12 months (Day 364), 18 monts (Day 546) and 24 months (Day 728) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Marta Herrero - Clinical R&D Manager
Organization: Bioiberica
phone: +34934904908
e-mail: mherrero@bioiberica.com



Responsible Party: Bioiberica
ClinicalTrials.gov Identifier: NCT01354145     History of Changes
Other Study ID Numbers: CS/III-DMOAD-02
Study First Received: May 13, 2011
Results First Received: February 18, 2016
Last Updated: July 12, 2016
Health Authority: Canada: Health Canada