Clinical trial NCT00992004: Evaluation of the Efficacy of a Turmeric Extract (Arantal®) in Patients With Osteoarthritis of the Knee (Gonarthrosis).
Official title: Comparative, Randomized, Double-blind, Placebo-controlled, Parallel Group Study, to Evaluate the Efficacy of a Turmeric Extract (Arantal®) Versus Placebo in Patients With Osteoarthritis of the Knee (Gonarthrosis).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis, Knee
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases
Lead sponsor: Bioxtract SA
Sponsor class: INDUSTRY
Collaborators: name: Nukleus
First posted: 2009-10-08
Enrollment: 280
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and the tolerance on 15 days of a turmeric extract (Arantal®) on pain related to gonarthrosis.


Eligibility criteria: Inclusion Criteria:

* Patient is 40 through 80 years of age
* Subject diagnosed with femorotibial osteoarthritis of the knee (diagnosed according to the clinical and radiologic criteria of ACR),
* Patient's Assessment of Arthritis Pain measurement on the last 24 hours of at least 50 mm on VAS,
* Patient has not received any NSAIDs within 72 hours and any analgesics within 24 hours,
* Patients with chronic knee pain (i.e., knee pain at least every other day during the month preceding inclusion),
* Patients with radiologic knee osteoarthritis (Kellgren-Lawrence grade 2-4, on radiography less than 12 months old),
* Patients having signed the informed consent,
* Patients capable of comprehend the study instructions.

Exclusion Criteria:

* Related to the osteoarthritis pathology:

  * Osteoarthritis linked to a metabolic arthropathy: chondrocalcinosis already diagnosed or defined by calcium edging on at least one femorotibial joint space, gout...,
  * Predominant associated symptomatic femoropatellar osteoarthritis,
  * Chondromatosis or villonodular synovitis of the knee,
  * Recent trauma (\< 1 month) of the knee responsible for the pain,
  * Knee joint effusion justifying an evacuation through puncturing,
  * Inflammatory flare (night pain, joint effusion) corresponding to a KOFUS score less than 7,
  * Pathology potentially interfering with the evaluation (metabolic inflammatory arthropathy, rheumatoid arthritis, lower limb radiculalgia, arthritis...),
* 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,
  * Patient who took NSAID in the 72 hours prior to inclusion or Analgesics in the 24 hours prior to inclusion,
  * Slow-acting drugs for OA and/or dietary supplements taken within less than 3 months prior to the study product administration or for which the dose has been modified in the last three months (ex: chondroitin sulfate, diacerein, soy and avocado unsaponifiables, oxaceprol, granions de cuivre, glucosamine, phytotherapy for OA, homeopathy for OA...),
  * Anticoagulant treatment without gastric protection,
  * General corticotherapy,
  * Contraindication to paracetamol.
* Related to associated pathologies:

  * Patient suffering from serious associated illness (liver failure, kidney failure, non-controlled cardiovascular diseases...),
  * Peptic ulcer.
* 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: Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
timeFrame: 15 days
Secondary outcomes:
measure: Kinetics of the analgesic effect by a variance analysis in repeated measures (Likert Scale)
timeFrame: 15 days
Other outcomes:
Locations:
city: Creteil
country: France
facility: Henri Mondor Hospital
Study officials:
affiliation: University of Liege - Bone and Cartilage Research Unit
name: Yves Henrotin, Pr
role: PRINCIPAL_INVESTIGATOR
References: