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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bioiberica
ClinicalTrials.gov Identifier:
NCT01425853
First received: August 25, 2011
Last updated: January 29, 2016
Last verified: January 2016
  Purpose
The purpose of this study is to determine whether the combination of Chondroitin sulfate (CS) and Glucosamine Hydrochloride (GH) has similar efficacy to Celecoxib (CE) in the treatment of patients with moderate to severe knee osteoarthritis (OA).

Condition Intervention Phase
Knee Osteoarthritis
Drug: Chondroitin/Glucosamine (Droglican)
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 ]
    Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale Score Range: 0 (no pain) - 500 (maximum pain) The study was designed such that the outcome of primary interest is knee pain related to OA. The measure selected to best evaluate this is an improvement in the WOMAC pain subscales. This subscale consists of 5 items which assesses the pain during walking, using stairs, in bed, sitting or lying, and standing.


Secondary Outcome Measures:
  • WOMAC Stiffness Subscale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Stiffness to 200 Maximum Stiffness WOMAC stiffness subscale was used to measure the stiffness of the knee with pain. Two items are used to assess stiffness grade: after first waking and later in the day.

  • WOMAC Function Subscale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Western Ontario & McMaster Universities Osteoarthritis Index, from 0 No Function to 1700 Maximum Function WOMAC functional limitation subscale was used to measure the functionality of the knee with pain. Seventeen items are used to assess functionality of the knee: tair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties.

  • Huskisson's VAS [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Visual Analogue Scale: 0 No Pain 100 Maximum Pain Huskisson's VAS measures global pain intensity. Patients were asked to quantify their disease status on a 100 mm VAS as follows: "Please indicate the severity of knee pain experienced during the last 48 hours by marking a (I) through the line". Left hand marker represents "No pain" and right hand marker represents "The worst pain imaginable".

  • Percentage of Participants With Response as Defined by Outcome Variables for Osteoarthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    The OARSI Standing Committee for Clinical Trials Response Criteria Initiative and the OMERACT committee, in concert with the international rheumatology community, has led to the development of a uniform core set of outcome measures for OA. One of the objectives was to propose a set of criteria for measurement based on multiple domains to present the results of changes after treatment in symptomatic parameters as a single variable for clinical trials.

    To be considered as responder patients should met one the following criteria:

    • High improvement in pain or in function ≥ 50% and absolute change ≥ 20 or
    • Improvement in at least 2 of the 3 following:

      • Pain ≥ 20% and absolute change ≥ 10
      • Function ≥ 20% and absolute change ≥ 10
      • Patient's global assessment ≥ 20% and absolute change ≥ 10

  • Percentage of Presence of Joint Swelling [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion.

  • Percentage of Presence of Joint Effusion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion.

  • Consumption of Rescue Medication [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Use of rescue medication as number of paracetamol tablets 500 mg since the last visit. The tablet count was reconciled with the patient diary.

    Total Number of pills per month


  • Patient's Global Assessment (PGA) and Investigator's Global Assessment (IGA) of Disease Activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Patients were asked to quantify their disease status on a VAS scale with range 0 mm (best) and 100 mm (worst) as follows: "Considering all the ways your arthritis of the knee affects you, mark (I) on the scale how well you are doing." Left hand marker "Very Well", Right hand marked "Very Poor".

  • Patient's and Investigator's Global Assessment of Response to Therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The investigator were asked to evaluated the patient's response to therapy of the index knee by marking a (I) a VAS scale with range 0 mm (best) and 100 mm (worst) as follows: Left hand marker "Excellent-Best possible anticipated response, considering the severity and stage of the disease", right hand marker "None-no response, absence of drug effect".

  • Health Status According to EuroQoL [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    EuroQoL-5D was a standardized instrument for use as a measure of health outcome that provides a simple descriptive profile and a single index value for health status. It was assessed at all of the study visits.

    The EQ-5D-3L essentially consists of 2 pages - the EQ-5D descriptive system (page 2) and the EQ visual analogue scale (EQ VAS) (page 3). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. Total scale range for each dimension reported is 1 to 3.

    The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.

    Total scale range for VAS dimension reported is 0 to 100.


  • Number of Participants With at Least One Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The safety evaluation was done in the set of randomized patients who took at least one dose of the medication

  • Number of Adverse Events Defined by Relationship With Treatment [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The safety evaluation was done in the set of randomized patients who took at least one dose of the medication

  • Biomarker Analysis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The following biomarkers will be evaluated: COMP, Coll2-1, Coll2-1 NO2 and Fib3-2


Enrollment: 606
Study Start Date: September 2011
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chondroitin/Glucosamine (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.

Drug: Chondroitin/Glucosamine (Droglican)
Experimental
Other Name: Chondroitin sulfate/ Glucosamine hydrochloride
Active Comparator: Celecoxib
Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Drug: Celecoxib
Active comparator

Detailed Description:
The primary objective of this study is to show that the combination treatment CS/GH has comparable efficacy to CE in pain reduction from baseline to 6 months of treatment measured with the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale in knee OA patients with moderate to severe pain.
  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
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 American College of Rheumatology (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 cardiovascular (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 Upper Gastrointestinal (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 beginning the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Spain
Hospital Universitario La Paz
Madrid, Spain, 28046
Sponsors and Collaborators
Bioiberica
Investigators
Principal Investigator: Jordi Monfort, MD Principal Investigator
  More Information

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 
Study First Received: August 25, 2011
Results First Received: July 20, 2015
Last Updated: January 29, 2016
Health Authority: Spain: Spanish Agency of Medicines
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Poland: National Institute of Medicines
Individual Participant Data  
Plan to Share IPD: Undecided

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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 28, 2016