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Exploratory Non Comparative Study to Evaluate the Efficacy of Highly Bioavailable Curcumin (Flexofytol) in Patients With Knee Osteoarthritis

ClinicalTrials.gov ID NCT01909037
Sponsor Tilman S.A.
Information provided by Tilman S.A. (Responsible Party)
Last Update Posted 2015-06-23
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Study Overview

Brief Summary
The purpose of this study is to evaluate the efficacy of bio-optimized curcumin(Flexofytol) during a 90-days period in knee ostearthritis patients on the serum levels of specific biomarkers of osteoarthritis and on the evaluation of pain.
Official Title
Exploratory Non Comparative Study to Evaluate the Efficacy of Highly Bioavailable Curcumin (Flexofytol) in Patients With Knee Osteoarthritis
Conditions
Knee Osteoarthritis
Intervention / Treatment
  • Dietary Supplement: Flexofytol (bio-optimized curcumin)
  • Dietary Supplement: Flexofytol (bio-optimized curcumin)
Other Study ID Numbers
  • TILFLEXFY 002
Study Start
2012-03
Primary Completion (Actual)
2012-12
Study Completion (Actual)
2012-12
Enrollment (Actual)
22
Study Type
Interventional
Phase
Early Phase 1

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 1 location
Belgium
Liege, Belgium, 4000

Citadelle Hospital
Click to view interactive map

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.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

Inclusion Criteria:

  • 45 to 80 years of age
  • Internal femorotibial gonarthrosis responding to the clinical and radiological criteria of ACR
  • Symptomatic knee for more than 6 months
  • Mean knee pain on the last 24 hours of at least 40 mm on VAS
  • Kellgren & Laurence grade II to III
  • Patients able to avoid NSAIDs and analgesics during the study
  • Patients having signed informed consent
  • Patients able to follow the study instructions

Exclusion Criteria:

  • Related to the osteoarthritis pathology:

    • Osteoarthritis linked to a metabolic arthropathy
    • Predominant associated symptomatic femoropatellar osteoarthritis
    • Chondromatosis or villonodular synovitis of the knee
    • Recent trauma (< 1 month) of the knee responsible for the pain
    • Inflammatory flare
    • Pathology potentially interfering with the evaluation (metabolic inflammatory arthropathy, rheumatoid arthritis, lower limb radiculalgia, arthritis...
    • Paget disease
    • Homolateral coxarthrosis
    • Articular Prosthesis
    • Knee joint effusion
  • Related to previous and associated treatments:

    • Corticosteroids injection in the previous month, whatever the joint concerned,
    • Hyaluronan injection in the evaluated knee during the previous 6 months,
    • NSAID or analgesics in the 72 hours prior to inclusion
    • No modification of Slow-acting drugs for OA and/or dietary supplements taken within less than 6 months prior to the study(ex: chondroitin sulfate, diacerein, soy and avocado unsaponifiables, oxaceprol, granions de cuivre, glucosamine, phytotherapy for OA, homeopathy for OA...),
    • Anticoagulant (coumarinic) treatment and heparin
    • General corticotherapy,
    • Contraindication to paracetamol.
  • Related to associated pathologies:

    • Patient suffering from serious associated illness (liver failure, kidney failure, non-controlled cardiovascular diseases...)
  • Related to patients:

    • Pregnant or breastfeeding women
    • Pre-menopausal women with no contraception
    • Patients unable to write
    • Patients enrolled in a clinical trial in the previous 3 months
    • Patients under juristic protection or under guardianship.
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Ages Eligible for Study
45 Years to 75 Years (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

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

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Design Details
Primary Purpose : Treatment
Allocation : N/A
Interventional Model : Single Group Assignment
Masking : None (Open Label)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: Flexofytol (bio-optimized curcumin) Intervention/Treatment Dietary Supplement: Flexofytol (bio-optimized curcumin)
  • 2x3 caps/day (before breakfast and in the evening) for 3 months

Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Serum levels of biomarkers of cartilage metabolism and inflammationChange from baseline of serum levels of biomarkers84 days
Secondary Outcome Measures
Outcome Measure Measure Description Time Frame
Pain and the global patient assessment of disease activity using a Visual Analog Scale (VAS)Change from baseline of the mean pain over the last 24 hours and of the global assessment of disease activity by the patient84 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Tilman S.A.
Collaborators
  • Bioxtract SA
Investigators
  • Principal Investigator:Caroline Castermans, MD,Citadelle Hospital of Liege
  • Study Director:Yvan Dierckxsens,Tilman S.A.

Publications

From PubMed

These publications come from PubMed, a public database of scientific and medical articles. This list is automatically created by ClinicalTrials.gov Identifier (NCT Number), and these articles may or may not be about the study.

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 Registration Dates
First Submitted
2013-07-18
First Submitted that Met QC Criteria
2013-07-25
First Posted (Estimated)
2013-07-26
Study Record Updates
Last Update Submitted that met QC Criteria
2015-06-22
Last Update Posted (Estimated)
2015-06-23
Last Verified
2013-07

More Information

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Keywords Provided by Tilman S.A.
Additional Relevant MeSH Terms