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Study on Efficacy and Safety of Chondroitin Sulfate + Glucosamine Hydrochloride Versus Celecoxib in Knee Osteoarthritis (MOVES)

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ClinicalTrials.gov Identifier: NCT01425853
Recruitment Status : Completed
First Posted : August 30, 2011
Results First Posted : February 26, 2016
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
Bioiberica

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: Chondroitin/Glucosamine (Droglican)
Drug: Celecoxib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)

Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.

Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.

Chondroitin sulfate/ Glucosamine hydrochloride

Celecoxib

Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.

Celecoxib


Participant Flow:   Overall Study
    Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)   Celecoxib
STARTED   304   302 
Safety Population   304   299 
Per Protocol (PP)   264   258 
COMPLETED   240   225 
NOT COMPLETED   64   77 



  Baseline Characteristics

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.
PP population was defined as all randomized patients who met the inclusion criteria, received study medication, had a baseline efficacy measurement and at least one corresponding post-baseline efficacy measurement (for the main efficacy variable) and did not present major violations of the protocol (n=522).

Reporting Groups
  Description
Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)

Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.

Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX.

Chondroitin sulfate/ Glucosamine hydrochloride

Celecoxib

Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.

Celecoxib

Total Total of all reporting groups

Baseline Measures
   Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)   Celecoxib   Total 
Overall Participants Analyzed 
[Units: Participants]
 264   258   522 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.22  (8.81)   63.16  (9.02)   62.68  (8.92) 
Gender 
[Units: Participants]
     
Female   229   209   438 
Male   35   49   84 
WOMAC Pain Subscale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 371.97  (41.76)   370.60  (41.15)   371.29  (41.57) 
[1] Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Pain to 500 Maximum Pain


  Outcome Measures

1.  Primary:   WOMAC Pain Subscale   [ Time Frame: 6 months ]

2.  Secondary:   WOMAC Stiffness Subscale   [ Time Frame: 6 months ]

3.  Secondary:   WOMAC Function Subscale   [ Time Frame: 6 months ]

4.  Secondary:   Huskisson’s VAS   [ Time Frame: 6 months ]

5.  Secondary:   Percentage of Participants With Response as Defined by Outcome Variables for Osteoarthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI)   [ Time Frame: 6 months ]

6.  Secondary:   Percentage of Presence of Joint Swelling   [ Time Frame: 6 months ]

7.  Secondary:   Percentage of Presence of Joint Effusion   [ Time Frame: 6 months ]

8.  Secondary:   Consumption of Rescue Medication   [ Time Frame: 6 months ]

9.  Secondary:   Patient’s Global Assessment (PGA) and Investigator's Global Assessment (IGA) of Disease Activity   [ Time Frame: 6 months ]

10.  Secondary:   Patient’s and Investigator's Global Assessment of Response to Therapy   [ Time Frame: 6 months ]

11.  Secondary:   Health Status According to EuroQoL   [ Time Frame: 6 months ]

12.  Secondary:   Number of Participants With at Least One Adverse Events   [ Time Frame: 6 months ]

13.  Secondary:   Number of Adverse Events Defined by Relationship With Treatment   [ Time Frame: 6 months ]

14.  Secondary:   Biomarker Analysis   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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:  
Name/Title: Clinical R&D Manager
Organization: Bioiberica
phone: +34934904908
e-mail: mherrero@bioiberica.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bioiberica
ClinicalTrials.gov Identifier: NCT01425853     History of Changes
Other Study ID Numbers: DRO/IV-ART-01
2010-024010-61 ( EudraCT Number )
First Submitted: August 25, 2011
First Posted: August 30, 2011
Results First Submitted: July 20, 2015
Results First Posted: February 26, 2016
Last Update Posted: February 26, 2016