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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Bioiberica

ClinicalTrials.gov Identifier:

NCT01425853

First received: August 25, 2011

Last updated: December 19, 2012

Last verified: December 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	August 25, 2011
Last Updated Date	December 19, 2012
Start Date ^ICMJE	September 2011
Estimated Primary Completion Date	May 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 29, 2011)	WOMAC Pain subscale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01425853 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 29, 2011)	WOMAC Stiffness Subscale [ Time Frame: 6 months ] [ Designated as safety issue: No ] WOMAC Function Subscale [ Time Frame: 6 months ] [ Designated as safety issue: No ] Huskisson's VAS [ Time Frame: 6 months ] [ Designated as safety issue: No ] OMERACT-OARSI set of responder criteria [ Time Frame: 6 months ] [ Designated as safety issue: No ] Presence or absence of joint swelling and/or effusion [ Time Frame: 6 months ] [ Designated as safety issue: No ] Consumption of rescue medication [ Time Frame: 6 months ] [ Designated as safety issue: No ] Patient's and investigator's global assessment of disease activity [ Time Frame: 6 months ] [ Designated as safety issue: No ] Patient's and investigator's global assessment of response to therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ] Health status according to EuroQoL [ Time Frame: 6 months ] [ Designated as safety issue: No ] Number of Participants with Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] Biomarker analysis [ Time Frame: 6 momths ] [ Designated as safety issue: No ] The following biomarkers will be evaluated: COMP, Coll2-1, Coll2-1 NO2 and Fib3-2
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study on the Efficacy and Safety of Chondroitin Sulfate and Glucosamine Hydrochloride Versus Celecoxib in Knee Osteoarthritis Treatment
Official Title ^ICMJE	Non-Inferiority Clinical Trial On The Efficacy And Safety Of Chondroitin Sulfate And Glucosamine Hydrochloride In Combination Versus Celecoxib In Patients With Knee Osteoarthritis
Brief Summary	The purpose of this study is to determine whether the combination of Chondroitin sulfate and Glucosamine hydrochloride has similar efficacy to Celecoxib in the treatment of patients with moderate to severe knee osteoarthritis.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Knee Osteoarthritis
Intervention ^ICMJE	Drug: Chondroitin sulfate/ Glucosamine hydrochloride Drug: Celecoxib
Study Arm (s)	Experimental: Chondroitin sulfate/ Glucosamine hydrochloride (Droglican) Intervention: Drug: Chondroitin sulfate/ Glucosamine hydrochloride Active Comparator: Celecoxib Intervention: Drug: Celecoxib
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	607
Completion Date	Not Provided
Estimated Primary Completion Date	May 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: At least 40 years of age Primary OA of the knee according to the ACR criteria OA of radiological stages II or III according to Kellgren and Lawrence Patients with moderate-severe knee pain Exclusion Criteria: Subjects with active malignancy of any type or history of a malignancy within the last five years 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 spondylo-arthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease Pain in other parts of the body greater than the knee pain that could interfere with the evaluation of the index joint Patients with fibromyalgia Subjects with a history of heart attack or stroke, or who have experienced chest pain related to heart disease, or who have had serious diseases of the heart Subjects with high risk of CV events Subjects with any active acute or chronic infections requiring antimicrobial therapy, or serious viral (e.g., hepatitis, herpes zoster, HIV positivity) or fungal infections Subjects with a history of recurrent UGI ulceration or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), a significant coagulation defect Subjects who have been diagnosed as having or have been treated for oesophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication Washout period for OA treatments before begginning the study.
Gender	Both
Ages	40 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Spain

Administrative Information
NCT Number ^ICMJE	NCT01425853
Other Study ID Numbers ^ICMJE	DRO/IV-ART-01, 2010-024010-61
Has Data Monitoring Committee	Yes
Responsible Party	Bioiberica
Study Sponsor ^ICMJE	Bioiberica
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Bioiberica
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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