Condrosulf vs Celebrex vs Placebo in the Treatment of Knee OA

March 1, 2017 updated by: IBSA Institut Biochimique SA

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
604

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other Names:
  • Condrosulf
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
Other Names:
  • placebo for chondroitin sulfate and placebo for celecoxib
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
Other Names:
  • Celebrex

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 1 and 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
Day 1 and Day 182

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lequesne's Index
Time Frame: Day 1, 30, 90 and 182
Evolution from Day 1 to Day 30, Day 90 and Day 182
Day 1, 30, 90 and 182
Pain (VAS in mm)
Time Frame: Day 1, 30, 91 and 182
Evolution of the pain on VAS (in mm) from Day 1 to Day 30, Day 91 and Day 182
Day 1, 30, 91 and 182
MCII (minimal clinically important improvement)
Time Frame: Day 1, 30, 91 and 182
Day 1, 30, 91 and 182
PASS (patient acceptable symptom state)
Time Frame: Day 1, 30, 91 and 182
Day 1, 30, 91 and 182
Consumption of Paracetamol
Time Frame: Day 1, 30, 91 and 182
Day 1, 30, 91 and 182
Global efficacy assessment
Time Frame: At Day 30, 91 and 182
Global efficacy assessed by the patient and the Investigator by means of a semi-quantitative verbal scale.
At Day 30, 91 and 182
Number of adverse events related to the treatments
Time Frame: At Day 30, 91 and 182
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
At Day 30, 91 and 182

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Treatment compliance
Time Frame: Day 1, 30, 91 and 182
Day 1, 30, 91 and 182

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IBSA Institut Biochimique SA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean-Yves Reginster, Prof. MD PhD, Unité d'Exploration du Métabolisme Osseux, CHU Centre ville, Polycliniques Universitaires L-Brull, Liège, Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 12, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 19, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 16, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12EU/Ct06
  • 2013-001619-62 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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