NCT00992004

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 7, 2010

Status Verified

May 1, 2010

Enrollment Period

11 months

First QC Date

October 7, 2009

Last Update Submit

May 6, 2010

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis, KneeOsteoarthritisJoint DiseasesArthritisRheumatic Diseases

Outcome Measures

Primary Outcomes (1)

  • Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)

    15 days

Secondary Outcomes (1)

  • Kinetics of the analgesic effect by a variance analysis in repeated measures (Likert Scale)

    15 days

Study Arms (2)

Arantal®

EXPERIMENTAL

Highly bioavailable turmeric extract (food supplement)

Dietary Supplement: Arantal® (highly bioavailable turmeric extract)

Placebo

PLACEBO COMPARATOR

Same capsule without the active ingredients (only excipients)

Dietary Supplement: Arantal® (highly bioavailable turmeric extract)

Interventions

Arantal® (highly bioavailable turmeric extract)DIETARY_SUPPLEMENT

4 capsules a day, before breakfast

Arantal®Placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 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.

You may not qualify if:

  • 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,
  • 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.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henri Mondor Hospital

Créteil, 94000, France

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisJoint DiseasesArthritisRheumatic Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Yves Henrotin, Pr

    University of Liege - Bone and Cartilage Research Unit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 8, 2009

Study Start

June 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

May 7, 2010

Record last verified: 2010-05

Locations

FR(1)