Knee OsteoarthritisPhase 3NCT02079727
Condrosulf vs Celebrex vs Placebo in the Treatment of Knee OA
A Phase 3 study testing chondroitin sulfate and celecoxib in people with Knee Osteoarthritis, run by IBSA Institut Biochimique SA at 16 sites in 5 countries.
Trial summary
The purpose of this study is to confirm the efficacy and safety of 800 mg Chondroitin 4\&6 sulfate (Condrosulf) vs placebo once a day for 6 months in the symptomatic treatment of knee osteoarthritis. A third group, Celecoxib 200 mg (Celebrex) once a day, will be used as active comparator. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- chondroitin sulfate and celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 604 participants
- Where
- 16 sitesin 5 countries
- Study dates
- 12 Jun 2014to 16 Jun 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients of either sex, aged ≥50 years
- Patients affected by primary knee osteoarthritis of the medial or lateral femoro-tibial compartment
- Diagnosis according to the American College of Rheumatology (ACR) criteria
- Kellgren \& Lawrence grade I-III
- Knee osteoarthritis evolving for more than 6 months
- Patients suffering from regular pain and functional disorders from at least 3 months
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- Accomplishing a score ≥ 7 of Lequesne's index for the knee osteoarthritis
- Assessing pain on Huskisson's VAS ≥ 50 mm
- With radiography dated less than six months showing a remaining articular joint space
- Without such an axial disorder to justify an osteotomy
- Women taking contraceptive measures if not in menopause
- Women having negative pregnancy test
- Patients able to understand and follow the study protocol
- Patients who have signed the written informed consent for their participation in the clinical trial
Who cannot join
- With a history of heart attack, ischemic heart disease or cerebrovascular disease (including transient ischemic attacks)
- Having or have had peripheral arterial disease or past surgery orf peripheral arteries
- With a history or currently significat coagulation defect or/and blood dyscrasia
- With high risk of cardiovascular events
- With any acute or chronic infections requiring antimicrobial therapy or serious viral (e.g., hepatitis, HIV positivity) or fungal infections
- With a history of recurrent gastrointestinal ulceration or active inflammatory bowel diseases (e.g., Crohn's disease or ulcerative colitis)
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- Having 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
- Having severe liver or kidney disease
- With allergy to Celebrex or any of the other ingredients of Celebrex
- Having had an allergic reaction to sulphonamides
- Having had, as a result of intake of acetylsalicylic acid or other NSAIDs, asthma, nose polyps, severe nose congestion, or an allergic reaction such as itchy skin rash, swelling of the face, lips, tongue or throat, breathing difficulties or wheezing
- Presenting lactose intolerance
- Mild or not symptomatic knee osteoarthritis : < 7 of Lequesne's index,
- Pain on Huskisson's VAS (Visual Analogic Scale) < 50 mm
- Predominantly femoro-patellar osteoarthritis
- Destructive osteoarthritis of the knee justifying a surgery in the following 6 months
- Osteoarthritis with hydrarthrosis requiring a puncture or an infiltration
- Important genu varum or valgus >8° (physiological angle including)
- Kellgren \& Lawrence grade IV
- Knee joint surgery in the last 3 months (e.g. chondroscopy, arthroscopy)
- Viscosupplementation, tidal lavage in the last 6 months
- Arthritis and metabolic arthropathies, Paget's illness
- Having consumed: basic treatment of arthritis with SYSADOA, symptomatic slow acting drugs for osteoarthrithis (chondroitin sulphates, glucosamine sulphates, diacerhein, hyaluronic acid and food supplement for joint care) in the last 3 months; treatment with corticoids, by any administration route during the last month; any medication having an influence on pain:
- NSAIDs (nonsteroidal anti-inflammatory drugs) in the 5 days preceding the inclusion (wash-out period considering 5 half-lives of the drug)
- hypnotics, muscle relaxants, anxiolytics, if the intake has started less than 8 days before inclusion
- paracetamol in the 10 hours preceding the inclusion
- Foreseen physiotherapy, re-education, alternative medicine (mesotherapy, acupuncture) in the next six months (study period)
- Presenting psychiatric illness hindering the protocol complaince, alcoholism, ongoing or < 1 year drug dependency
- Pregnant or likely to become it during clinical trial or lactating
- Women having positive pregnancy test
- Having participated in other clinical trials in the month preceding the clinical trial.
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
Czechia6 sites
Interni a revmatologicka ordinace
Břeclav
Ortopedicka Ambulance
Brno
Vesalion s.r.o.
Ostrava
Revmatologicky ustav
Prague
Thomayerova nemocnice - Revmatologicke a rehabilitacne oddeleni
Praha - Krc
Medical Plus
Uherské Hradiště
Poland5 sites
Klinika Zdrowej Kosci
Lodz
Lubelskie Centrum Diagnostyczne
Świdnik
SOLB
Ul. Jana III Sobieskiego
Medica Pro Familia
Warsaw
Zdrowie Osteo-Medic
Wiejska
Switzerland3 sites
Bethesda-Spital
Basel
HFR Fribourg - Hôpital Cantonal
Fribourg
Universitätsspital Zürich, Rheumaklinik
Zurich
Belgium1 site
Unité d'exploration du metabolism osseux, CHU, Polyclinique universitaires L-Brull
Liège, Liege, 4020
About this study
Official title: A Multicentre, Comparative, Randomised, Double-blind, Double-dummy Clinical Trial on the Efficacy and Safety of Condrosulf Versus Celebrex and Versus a Placebo in the Treatment of Knee Osteoarthritis
The purpose of this study is to confirm the efficacy and safety of 800 mg Chondroitin 4\&6 sulfate (Condrosulf) vs placebo once a day for 6 months in the symptomatic treatment of knee osteoarthritis. A third group, Celecoxib 200 mg (Celebrex) once a day, will be used as active comparator.
- Conditions
- Knee Osteoarthritis
- Being tested
- chondroitin sulfate, celecoxib, placebo
- Keywords
- Condrosulf, Chondroitin sulfate, Celebrex, Knee OA, Knee osteoarthritis
- 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 sulfateDrug
Also called Condrosulf
celecoxibDrug
Also called Celebrex
placeboDrug
Also called placebo for chondroitin sulfate and placebo for celecoxib
| Study group | Role | What they receive |
|---|---|---|
| Condrosulf (Chondroitin 4&6 sulfate) | Experimental | 1 tablet of Condrosulf 800 mg and 1 capsule of placebo of Celebrex once a day for 182 days Receives: Drug: chondroitin sulfate |
| Placebo (PBO) 800 mg tablet and Placebo (PBO) 200 mg capsule | Placebo comparator | 1 tablet of PBO of Condrosulf and 1 capsule of PBO of Celebrex, once a day for 182 days Receives: Drug: placebo |
| Celebrex 200 mg capsule | Active comparator | 1 capsule of 200 mg of Celebrex and 1 tablet of 800 mg placebo of Condrosulf once a day for 182 days Receives: Drug: celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lequesne's Index
Decrease in the scores of the Lequesne's Index from Day 1 to Day 182.
Measured: Day 1 and Day 182
Pain (VAS in mm)
Decrease in the VAS (pain in mm) from Day 1 to Day 182
Measured: Day 1 and Day 182
Secondary outcomes (8)
Lequesne's Index
Evolution from Day 1 to Day 30, Day 90 and Day 182
Measured: Day 1, 30, 90 and 182
Pain (VAS in mm)
Evolution of the pain on VAS (in mm) from Day 1 to Day 30, Day 91 and Day 182
Measured: Day 1, 30, 91 and 182
MCII (minimal clinically important improvement)
Measured: Day 1, 30, 91 and 182
PASS (patient acceptable symptom state)
Measured: Day 1, 30, 91 and 182
Consumption of Paracetamol
Measured: Day 1, 30, 91 and 182
Global efficacy assessment
Global efficacy assessed by the patient and the Investigator by means of a semi-quantitative verbal scale.
Measured: At Day 30, 91 and 182
Number of adverse events related to the treatments
Measured: At Day 30, 91 and 182
Number of drop-outs due to AE (adverse event) related to the treatment
Measured: At Day 30, 91 and 182
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study start12 Jun 2014
- Primary completion19 Oct 2015
- Study completion16 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBSA Institut Biochimique SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Yves Reginster, Prof. MD PhD, Principal investigator, Unité d'Exploration du Métabolisme Osseux, CHU Centre ville, Polycliniques Universitaires L-Brull, Liège, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079727
- Sponsor's protocol ID
- 12EU/Ct06
- Other IDs
- 2013-001619-62
- Status last verified
- Mar 2017
- First submitted
- 28 Feb 2014
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Comparative, Randomised, Double-blind, Double-dummy Clinical Trial on the Efficacy and Safety of Condrosulf Versus Celebrex and Versus a Placebo in the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02079727
- Acronym / sponsor ID
- 12EU/Ct06
- Conditions
- Knee Osteoarthritis
- Keywords
- Condrosulf, Chondroitin sulfate, Celebrex, Knee OA, Knee osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- IBSA Institut Biochimique SAIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2014 (actual)
- Primary completion
- 19 Oct 2015 (actual)
- Study completion
- 16 Jun 2016 (actual)
- First posted
- 6 Mar 2014 (estimated)
- Results
- Not posted in the source record
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 confirm the efficacy and safety of 800 mg Chondroitin 4\&6 sulfate (Condrosulf) vs placebo once a day for 6 months in the symptomatic treatment of knee osteoarthritis. A third group, Celecoxib 200 mg (Celebrex) once a day, will be used as active comparator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Condrosulf (Chondroitin 4&6 sulfate) | Experimental | Drug: chondroitin sulfate1 tablet of Condrosulf 800 mg and 1 capsule of placebo of Celebrex once a day for 182 days |
| Placebo (PBO) 800 mg tablet and Placebo (PBO) 200 mg capsule | Placebo comparator | Drug: placebo1 tablet of PBO of Condrosulf and 1 capsule of PBO of Celebrex, once a day for 182 days |
| Celebrex 200 mg capsule | Active comparator | Drug: celecoxib1 capsule of 200 mg of Celebrex and 1 tablet of 800 mg placebo of Condrosulf once a day for 182 days |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Outpatients of either sex, aged ≥50 years
- Patients affected by primary knee osteoarthritis of the medial or lateral femoro-tibial compartment
- Diagnosis according to the American College of Rheumatology (ACR) criteria
- Kellgren \& Lawrence grade I-III
- Knee osteoarthritis evolving for more than 6 months
Key exclusion criteria (31 listed)
- With a history of heart attack, ischemic heart disease or cerebrovascular disease (including transient ischemic attacks)
- Having or have had peripheral arterial disease or past surgery orf peripheral arteries
- With a history or currently significat coagulation defect or/and blood dyscrasia
- With high risk of cardiovascular events
- With any acute or chronic infections requiring antimicrobial therapy or serious viral (e.g., hepatitis, HIV positivity) or fungal infections
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 sulfateAlso: Condrosulf | Drug | Condrosulf (Chondroitin 4&6 sulfate) |
| celecoxibAlso: Celebrex | Drug | Celebrex 200 mg capsule |
| placeboAlso: placebo for chondroitin sulfate and placebo for celecoxib | Drug | Placebo (PBO) 800 mg tablet and Placebo (PBO) 200 mg capsule |
Primary outcome
Lequesne's Index
Time frame: Day 1 and Day 182
Decrease in the scores of the Lequesne's Index from Day 1 to Day 182.
Pain (VAS in mm)
Time frame: Day 1 and Day 182
Decrease in the VAS (pain in mm) from Day 1 to Day 182
8 secondary outcomes
Lequesne's Index
Time frame: Day 1, 30, 90 and 182
Pain (VAS in mm)
Time frame: Day 1, 30, 91 and 182
MCII (minimal clinically important improvement)
Time frame: Day 1, 30, 91 and 182
PASS (patient acceptable symptom state)
Time frame: Day 1, 30, 91 and 182
Consumption of Paracetamol
Time frame: Day 1, 30, 91 and 182
Global efficacy assessment
Time frame: At Day 30, 91 and 182
Number of adverse events related to the treatments
Time frame: At Day 30, 91 and 182
Number of drop-outs due to AE (adverse event) related to the treatment
Time frame: At Day 30, 91 and 182
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
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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.
Jean-Yves Reginster, Prof. MD PhD principal investigator
Unité d'Exploration du Métabolisme Osseux, CHU Centre ville, Polycliniques Universitaires L-Brull, Liège, Belgium
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing chondroitin sulfate and celecoxib in people with Knee Osteoarthritis, run by IBSA Institut Biochimique SA at 16 sites in 5 countries.
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 14 inclusion and 31 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 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Czechia, Poland, Switzerland, Belgium, Italy. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lequesne's Index (time frame: Day 1 and Day 182). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2017.