Knee OsteoarthritisPhase 4MOVESNCT01425853
Study on Efficacy and Safety of Chondroitin Sulfate + Glucosamine Hydrochloride Versus Celecoxib in Knee Osteoarthritis
A Phase 4 study testing Chondroitin/Glucosamine (Droglican) and Celecoxib in people with Knee Osteoarthritis, run by Bioiberica at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Chondroitin/Glucosamine (Droglican) and Celecoxib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 606 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2011to May 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Chondroitin/Glucosamine (Droglican), Celecoxib
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chondroitin/Glucosamine (Droglican)Drug
Also called Chondroitin sulfate/ Glucosamine hydrochloride
Experimental
CelecoxibDrug
Active comparator
| Study group | Role | What they receive |
|---|---|---|
| Chondroitin/Glucosamine (Droglican) | Experimental | 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. Receives: Drug: Chondroitin/Glucosamine (Droglican) |
| Celecoxib | Active comparator | Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH. Receives: Drug: Celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (13)
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.
Measured: 6 months
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.
Measured: 6 months
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".
Measured: 6 months
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
Measured: 6 months
Percentage of Presence of Joint Swelling
Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion.
Measured: 6 months
Percentage of Presence of Joint Effusion
Study knees were evaluated at each visit for the presence or absence of swelling and/or effusion.
Measured: 6 months
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
Measured: 6 months
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".
Measured: 6 months
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".
Measured: 6 months
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.
Measured: 6 months
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
Measured: 6 months
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
Measured: 6 months
Biomarker Analysis
The following biomarkers will be evaluated: COMP, Coll2-1, Coll2-1 NO2 and Fib3-2
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 606 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioiberica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jordi Monfort, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425853
- Sponsor's protocol ID
- DRO/IV-ART-01
- Other IDs
- 2010-024010-61
- Acronym
- MOVES
- Status last verified
- Jan 2016
- First submitted
- 25 Aug 2011
- Last updated
- 26 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 25589511
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01425853
- Acronym / sponsor ID
- MOVES / DRO/IV-ART-01
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 606 participants (actual)
- Lead sponsor
- BioibericaIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 30 Aug 2011 (estimated)
- Results
- Posted 26 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chondroitin/Glucosamine (Droglican) | Experimental | Drug: 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. |
| Celecoxib | Active comparator | Drug: CelecoxibActive ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chondroitin/Glucosamine (Droglican)Also: Chondroitin sulfate/ Glucosamine hydrochlorideExperimental | Drug | Chondroitin/Glucosamine (Droglican) |
| CelecoxibActive comparator | Drug | Celecoxib |
Primary outcome
WOMAC Pain Subscale
Time frame: 6 months
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.
13 secondary outcomes
WOMAC Stiffness Subscale
Time frame: 6 months
WOMAC Function Subscale
Time frame: 6 months
Huskisson's VAS
Time frame: 6 months
Percentage of Participants With Response as Defined by Outcome Variables for Osteoarthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI)
Time frame: 6 months
Percentage of Presence of Joint Swelling
Time frame: 6 months
Percentage of Presence of Joint Effusion
Time frame: 6 months
Consumption of Rescue Medication
Time frame: 6 months
Patient's Global Assessment (PGA) and Investigator's Global Assessment (IGA) of Disease Activity
Time frame: 6 months
Patient's and Investigator's Global Assessment of Response to Therapy
Time frame: 6 months
Health Status According to EuroQoL
Time frame: 6 months
Number of Participants With at Least One Adverse Events
Time frame: 6 months
Number of Adverse Events Defined by Relationship With Treatment
Time frame: 6 months
Biomarker Analysis
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25589511Hochberg 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordi Monfort, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chondroitin/Glucosamine (Droglican) and Celecoxib in people with Knee Osteoarthritis, run by Bioiberica at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC Pain Subscale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01425853, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016.