Back to resultsStudy on Efficacy and Safety of Chondroitin Sulfate + Glucosamine Hydrochloride Versus Celecoxib in Knee Osteoarthritis (MOVES)
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Chondroitin/Glucosamine (Droglican)
Celecoxib
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility 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.
Sites / Locations
- Hospital Universitario La Paz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Chondroitin/Glucosamine (Droglican)
Celecoxib
Arm Description
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.
Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Outcomes
Primary Outcome Measures
WOMAC Pain Subscale
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
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
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
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)
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
Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion.
Percentage of Presence of Joint Effusion
Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion.
Consumption of Rescue Medication
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
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
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
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
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
The safety evaluation was done in the set of randomized patients who took at least one dose of the medication
Biomarker Analysis
The following biomarkers will be evaluated: COMP, Coll2-1, Coll2-1 NO2 and Fib3-2
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01425853
Brief Title
Study on Efficacy and Safety of Chondroitin Sulfate + Glucosamine Hydrochloride Versus Celecoxib in Knee Osteoarthritis
Acronym
MOVES
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioiberica
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
606 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chondroitin/Glucosamine (Droglican)
Arm Type
Experimental
Arm Description
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.
Arm Title
Celecoxib
Arm Type
Active Comparator
Arm Description
Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Intervention Type
Drug
Intervention Name(s)
Chondroitin/Glucosamine (Droglican)
Other Intervention Name(s)
Chondroitin sulfate/ Glucosamine hydrochloride
Intervention Description
Experimental
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
Active comparator
Primary Outcome Measure Information:
Title
WOMAC Pain Subscale
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
WOMAC Stiffness Subscale
Description
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.
Time Frame
6 months
Title
WOMAC Function Subscale
Description
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.
Time Frame
6 months
Title
Huskisson's VAS
Description
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".
Time Frame
6 months
Title
Percentage of Participants With Response as Defined by Outcome Variables for Osteoarthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI)
Description
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
Time Frame
6 months
Title
Percentage of Presence of Joint Swelling
Description
Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion.
Time Frame
6 months
Title
Percentage of Presence of Joint Effusion
Description
Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion.
Time Frame
6 months
Title
Consumption of Rescue Medication
Description
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
Time Frame
6 months
Title
Patient's Global Assessment (PGA) and Investigator's Global Assessment (IGA) of Disease Activity
Description
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".
Time Frame
6 months
Title
Patient's and Investigator's Global Assessment of Response to Therapy
Description
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".
Time Frame
6 months
Title
Health Status According to EuroQoL
Description
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.
Time Frame
6 months
Title
Number of Participants With at Least One Adverse Events
Description
The safety evaluation was done in the set of randomized patients who took at least one dose of the medication
Time Frame
6 months
Title
Number of Adverse Events Defined by Relationship With Treatment
Description
The safety evaluation was done in the set of randomized patients who took at least one dose of the medication
Time Frame
6 months
Title
Biomarker Analysis
Description
The following biomarkers will be evaluated: COMP, Coll2-1, Coll2-1 NO2 and Fib3-2
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordi Monfort, MD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25589511
Citation
Hochberg MC, Martel-Pelletier J, Monfort J, Moller I, Castillo JR, Arden N, Berenbaum F, Blanco FJ, Conaghan PG, Domenech G, Henrotin Y, Pap T, Richette P, Sawitzke A, du Souich P, Pelletier JP; MOVES Investigation Group. Combined chondroitin sulfate and glucosamine for painful knee osteoarthritis: a multicentre, randomised, double-blind, non-inferiority trial versus celecoxib. Ann Rheum Dis. 2016 Jan;75(1):37-44. doi: 10.1136/annrheumdis-2014-206792. Epub 2015 Jan 14.
Results Reference
derived
Learn more about this trial
Study on Efficacy and Safety of Chondroitin Sulfate + Glucosamine Hydrochloride Versus Celecoxib in Knee Osteoarthritis
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