Clinical trial NCT01909037: Exploratory Non Comparative Study to Evaluate the Efficacy of Highly Bioavailable Curcumin (Flexofytol) in Patients With Knee Osteoarthritis
Official title: Exploratory Non Comparative Study to Evaluate the Efficacy of Highly Bioavailable Curcumin (Flexofytol) in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Knee Osteoarthritis
Keywords: osteoarthritis
curcumin
biomarker
pain
Lead sponsor: Tilman S.A.
Sponsor class: INDUSTRY
Collaborators: name: Bioxtract SA
First posted: 2013-07-26
Enrollment: 22
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Serum levels of biomarkers of cartilage metabolism and inflammation
timeFrame: 84 days
Secondary outcomes:
measure: Pain and the global patient assessment of disease activity using a Visual Analog Scale (VAS)
timeFrame: 84 days
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: Citadelle Hospital
Study officials:
affiliation: Citadelle Hospital of Liege
name: Caroline Castermans, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tilman S.A.
name: Yvan Dierckxsens
role: STUDY_DIRECTOR
References:
citation: Henrotin Y, Gharbi M, Dierckxsens Y, Priem F, Marty M, Seidel L, Albert A, Heuse E, Bonnet V, Castermans C. Decrease of a specific biomarker of collagen degradation in osteoarthritis, Coll2-1, by treatment with highly bioavailable curcumin during an exploratory clinical trial. BMC Complement Altern Med. 2014 May 17;14:159. doi: 10.1186/1472-6882-14-159.