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CompletedNCT02079727Updated Mar 3, 2017

Condrosulf vs Celebrex vs Placebo in the Treatment of Knee OA

A Phase 3 interventional study of chondroitin sulfate and celecoxib in Knee Osteoarthritis, sponsored by IBSA Institut Biochimique SA. Completed at 16 sites in 5 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2017-03-03.

Sponsored by IBSA Institut Biochimique SA · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
604
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • Condrosulf
  • Chondroitin sulfate
  • Celebrex
  • Knee OA
  • Knee osteoarthritis
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 604 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

IBSA Institut Biochimique SA is the lead sponsor of 33 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
604 participants (actual)

Study arms

  • Experimental
    Condrosulf (Chondroitin 4&6 sulfate)

    1 tablet of Condrosulf 800 mg and 1 capsule of placebo of Celebrex once a day for 182 days

    Drug: chondroitin sulfate

  • Placebo comparator
    Placebo (PBO) 800 mg tablet and Placebo (PBO) 200 mg capsule

    1 tablet of PBO of Condrosulf and 1 capsule of PBO of Celebrex, once a day for 182 days

    Drug: placebo

  • Active comparator
    Celebrex 200 mg capsule

    1 capsule of 200 mg of Celebrex and 1 tablet of 800 mg placebo of Condrosulf once a day for 182 days

    Drug: celecoxib

Interventions

  • Drugchondroitin sulfate

    Also known as: Condrosulf

  • Drugcelecoxib

    Also known as: Celebrex

  • Drugplacebo

    Also known as: placebo for chondroitin sulfate and placebo for celecoxib

06

What researchers measure

Primary outcomes

  1. Lequesne's Index

    Decrease in the scores of the Lequesne's Index from Day 1 to Day 182.

    Time frame: Day 1 and Day 182

  2. Pain (VAS in mm)

    Decrease in the VAS (pain in mm) from Day 1 to Day 182

    Time frame: Day 1 and Day 182

Secondary outcomes

  1. Lequesne's Index

    Evolution from Day 1 to Day 30, Day 90 and Day 182

    Time frame: Day 1, 30, 90 and 182

  2. Pain (VAS in mm)

    Evolution of the pain on VAS (in mm) from Day 1 to Day 30, Day 91 and Day 182

    Time frame: Day 1, 30, 91 and 182

  3. MCII (minimal clinically important improvement)

    Time frame: Day 1, 30, 91 and 182

  4. PASS (patient acceptable symptom state)

    Time frame: Day 1, 30, 91 and 182

  5. Consumption of Paracetamol

    Time frame: Day 1, 30, 91 and 182

  6. Global efficacy assessment

    Global efficacy assessed by the patient and the Investigator by means of a semi-quantitative verbal scale.

    Time frame: At Day 30, 91 and 182

  7. Number of adverse events related to the treatments

    Time frame: At Day 30, 91 and 182

  8. Number of drop-outs due to AE (adverse event) related to the treatment

    Time frame: At Day 30, 91 and 182

Other outcomes

  1. Treatment compliance

    Time frame: Day 1, 30, 91 and 182

07

Study locations

16 sites
  • Unité d'exploration du metabolism osseux, CHU, Polyclinique universitaires L-Brull
    Liege, 4020, Belgium
  • Interni a revmatologicka ordinace
    Breclav, Czech Republic
  • Ortopedicka Ambulance
    Brno, Czech Republic
  • Vesalion s.r.o.
    Ostrava, Czech Republic
  • Thomayerova nemocnice - Revmatologicke a rehabilitacne oddeleni
    Praha - Krc, Czech Republic
  • Revmatologicky ustav
    Praha 2, Czech Republic
  • Medical Plus
    Uherske Hradiste, Czech Republic
  • Azienda Osp. Univ. Di Careggi
    Firenze, Italy
  • Klinika Zdrowej Kosci
    Lodz, Poland
  • Lubelskie Centrum Diagnostyczne
    Swidnik, Poland
  • SOLB
    ul. Jana III Sobieskiego, Poland
  • Medica Pro Familia
    Warszawa, Poland
  • Zdrowie Osteo-Medic
    Wiejska, Poland
  • Bethesda-Spital
    Basel, Switzerland
  • HFR Fribourg - Hôpital Cantonal
    Fribourg, Switzerland
  • Universitätsspital Zürich, Rheumaklinik
    Zürich, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02079727
Lead sponsor
IBSA Institut Biochimique SA
Responsible party
Sponsor
First posted
Mar 6, 2014
Start date
Jun 12, 2014
Primary completion
Oct 19, 2015
Completion
Jun 16, 2016
Last update
Mar 3, 2017

Study contacts

Jean-Yves Reginster, Prof. MD PhD
principal investigator · Unité d'Exploration du Métabolisme Osseux, CHU Centre ville, Polycliniques Universitaires L-Brull, Liège, Belgium

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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