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
  Purpose

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.


Condition Intervention Phase
Knee Osteoarthritis
Drug: Chondroitin sulfate/ Glucosamine hydrochloride
Drug: Celecoxib
Phase 4

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
Official Title: Non-Inferiority Clinical Trial On The Efficacy And Safety Of Chondroitin Sulfate And Glucosamine Hydrochloride In Combination Versus Celecoxib In Patients With Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Bioiberica:

Primary Outcome Measures:
  • WOMAC Pain subscale [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Enrollment: 607
Study Start Date: September 2011
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chondroitin sulfate/ Glucosamine hydrochloride (Droglican) Drug: Chondroitin sulfate/ Glucosamine hydrochloride
Active Comparator: Celecoxib Drug: Celecoxib

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425853

Locations
Spain
Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Bioiberica
  More Information

No publications provided

Responsible Party: Bioiberica
ClinicalTrials.gov Identifier: NCT01425853     History of Changes
Other Study ID Numbers: DRO/IV-ART-01, 2010-024010-61
Study First Received: August 25, 2011
Last Updated: December 19, 2012
Health Authority: Spain: Spanish Agency of Medicines
France: Agence française de sécurité sanitaire des produits de la santé
Germany: Federal Institute for Drugs and Medical Devices
Poland: National Institute of Medicines

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 17, 2014