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

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ClinicalTrials.gov Identifier: NCT01909037
Recruitment Status : Completed
First Posted : July 26, 2013
Last Update Posted : June 23, 2015
Sponsor:
Collaborator:
Bioxtract SA
Information provided by (Responsible Party):
Tilman S.A.

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Dietary Supplement: Flexofytol (bio-optimized curcumin) Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploratory Non Comparative Study to Evaluate the Efficacy of Highly Bioavailable Curcumin (Flexofytol) in Patients With Knee Osteoarthritis
Study Start Date : March 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Curcumin

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




Primary Outcome Measures :
  1. Serum levels of biomarkers of cartilage metabolism and inflammation [ Time Frame: 84 days ]
    Change from baseline of serum levels of biomarkers


Secondary Outcome Measures :
  1. Pain and the global patient assessment of disease activity using a Visual Analog Scale (VAS) [ Time Frame: 84 days ]
    Change from baseline of the mean pain over the last 24 hours and of the global assessment of disease activity by the patient



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01909037


Locations
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Belgium
Citadelle Hospital
Liege, Belgium, 4000
Sponsors and Collaborators
Tilman S.A.
Bioxtract SA
Investigators
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Principal Investigator: Caroline Castermans, MD Citadelle Hospital of Liege
Study Director: Yvan Dierckxsens Tilman S.A.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tilman S.A.
ClinicalTrials.gov Identifier: NCT01909037     History of Changes
Other Study ID Numbers: TILFLEXFY 002
First Posted: July 26, 2013    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: July 2013

Keywords provided by Tilman S.A.:
osteoarthritis
curcumin
biomarker
pain

Additional relevant MeSH terms:
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Enzyme Inhibitors
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action