NCT02079727

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
604

participants targeted

Target at P75+ for phase_3 knee-osteoarthritis

Timeline
Completed

Started Jun 2014

Geographic Reach
5 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

June 12, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2016

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

1.4 years

First QC Date

February 28, 2014

Last Update Submit

March 1, 2017

Conditions

Knee Osteoarthritis

Keywords

CondrosulfChondroitin sulfateCelebrexKnee OAKnee osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • Lequesne's Index

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

    Day 1 and Day 182

  • Pain (VAS in mm)

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

    Day 1 and Day 182

Secondary Outcomes (8)

  • Lequesne's Index

    Day 1, 30, 90 and 182

  • Pain (VAS in mm)

    Day 1, 30, 91 and 182

  • MCII (minimal clinically important improvement)

    Day 1, 30, 91 and 182

  • PASS (patient acceptable symptom state)

    Day 1, 30, 91 and 182

  • Consumption of Paracetamol

    Day 1, 30, 91 and 182

  • +3 more secondary outcomes

Other Outcomes (1)

  • Treatment compliance

    Day 1, 30, 91 and 182

Study Arms (3)

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

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

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

Drug: celecoxib

Interventions

chondroitin sulfateDRUG
Also known as: Condrosulf
Condrosulf (Chondroitin 4&6 sulfate)
celecoxibDRUG
Also known as: Celebrex
Celebrex 200 mg capsule
placeboDRUG
Also known as: placebo for chondroitin sulfate and placebo for celecoxib
Placebo (PBO) 800 mg tablet and Placebo (PBO) 200 mg capsule

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Unité d'exploration du metabolism osseux, CHU, Polyclinique universitaires L-Brull

Liège, Liege, 4020, Belgium

Location

Ortopedicka Ambulance

Brno, Czechia

Location

Interni a revmatologicka ordinace

Břeclav, Czechia

Location

Vesalion s.r.o.

Ostrava, Czechia

Location

Revmatologicky ustav

Prague, Czechia

Location

Thomayerova nemocnice - Revmatologicke a rehabilitacne oddeleni

Praha - Krc, Czechia

Location

Medical Plus

Uherské Hradiště, Czechia

Location

Azienda Osp. Univ. Di Careggi

Florence, Italy

Location

Klinika Zdrowej Kosci

Lodz, Poland

Location

Lubelskie Centrum Diagnostyczne

Świdnik, Poland

Location

SOLB

Ul. Jana III Sobieskiego, Poland

Location

Medica Pro Familia

Warsaw, Poland

Location

Zdrowie Osteo-Medic

Wiejska, Poland

Location

Bethesda-Spital

Basel, Switzerland

Location

HFR Fribourg - Hôpital Cantonal

Fribourg, Switzerland

Location

Universitätsspital Zürich, Rheumaklinik

Zurich, Switzerland

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Chondroitin SulfatesCelecoxib

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

ChondroitinGlycosaminoglycansPolysaccharidesCarbohydratesBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jean-Yves Reginster, Prof. MD PhD

    Unité d'Exploration du Métabolisme Osseux, CHU Centre ville, Polycliniques Universitaires L-Brull, Liège, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2014

First Posted

March 6, 2014

Study Start

June 12, 2014

Primary Completion

October 19, 2015

Study Completion

June 16, 2016

Last Updated

March 3, 2017

Record last verified: 2017-03

Locations

PL(5)CZ(6)BE(1)CH(3)IT(1)