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

Early Phase 1

Completed

• Conditions: Knee Osteoarthritis

• Registration Number: NCT01909037
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-07
• Study First Submitted: 2013-07-18
• Study First Submitted QC: 2013-07-25
• Study First Posted: 2013-07-26
• Last Update Submitted: 2015-06-22
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Serum levels of biomarkers of cartilage metabolism and inflammation	84 days	Change from baseline of serum levels of biomarkers

Secondary Outcome Measures

Name	Time	Method
Pain and the global patient assessment of disease activity using a Visual Analog Scale (VAS)	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

Trial Locations

Locations (1)

Citadelle Hospital; 🇧🇪 Liege, Belgium