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Trial record 25 of 126 for:    turmeric

Evaluation of FLEXOFYTOL® Versus PLACEBO (COPRA)

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ClinicalTrials.gov Identifier: NCT02909621
Recruitment Status : Completed
First Posted : September 21, 2016
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
Artialis
Information provided by (Responsible Party):
Tilman S.A.

Brief Summary:

This study is a prospective, randomized, double-blind, placebo-controlled with 3 parallel-groups and multicenter trial in patients suffering from knee OA (osteoarthrosis).

A first exploratory non comparative study (TILFLEXY002, NCT01909037, Henrotin et al., 2014 BMC Complementary and Alternative Medicine) evaluated the efficacy of FLEXOFYTOL® at the dose of 2x3 caps/day, during a 3-month period, in 22 patients suffering from knee OA, on the serum levels of cartilage-specific and inflammatory biomarkers, on the evaluation of pain and on the global patient assessment of disease activity.

This study demonstrated a statistically significant decrease of sColl2-1 cartilage specific biomarker, an early decrease of the ultrasensitive C-reactive protein (CRP), an improvement of the global assessment of the disease by the patient as well as a good tolerance and compliance for the treatment. Results of this exploratory study are encouraging and justify the setup of a randomized, placebo-controlled double blind and dose-ranging trial.


Condition or disease Intervention/treatment Phase
Osteoarthritis Dietary Supplement: FLEXOFYTOL® Other: PLACEBO Not Applicable

Detailed Description:

150 patients suffering from symptomatic knee OA will be randomized in 3 parallel groups (50 patients per group). Each patient will be enrolled in the study for 6 months including 4 visits: Inclusion visit (T0), follow-up visits after 1 month (T1), 3 months (T3) and 6 months (T6).

A. Primary objective

- Evaluate the efficacy of two different dosages of FLEXOFYTOL® versus PLACEBO on arthritis related biomarker coll2-1 and on patient assessment of disease activity in patients suffering from knee OA after a 3 months treatment

B. Secondary objectives

  • Evaluate the efficacy of two different dosages of FLEXOFYTOL® versus PLACEBO on arthritis-related and inflammatory biomarkers.
  • Evaluate the efficacy of two different dosages of FL EXOFYTOL® versus PLACEBO on pain and function.
  • Evaluate the tolerance, the compliance and the patients' satisfaction.
  • Evaluate the use of rescue treatments i.e. Paracetamol and oral non-steroidal antiinflammatory drugs (NSAIDs) during the study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluation of Efficacy, Tolerance, and Dose Effects of a Curcuma Extract (FLEXOFYTOL®) Versus PLACEBO in Patients With Knee osteoARthritis (COPRA)
Study Start Date : May 2014
Actual Primary Completion Date : July 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: Group A
Group A: FLEXOFYTOL® high dosage
Dietary Supplement: FLEXOFYTOL®
The product FLEXOFYTOL® is bio-optimized curcumin.
Other Name: curcuma extract

Active Comparator: Group B
Group B: FLEXOFYTOL® low dosage
Dietary Supplement: FLEXOFYTOL®
The product FLEXOFYTOL® is bio-optimized curcumin.
Other Name: curcuma extract

Placebo Comparator: Group C
Group C: PLACEBO
Other: PLACEBO



Primary Outcome Measures :
  1. Variation of serum levels of sColl2-1 biomarker between T0 and T3 by specific immunoassays (Enzyme-linked Immunosorbent assay, ELISA). [ Time Frame: 3 months (between T0 and T3 visit) ]
  2. Variation of Global assessment of disease activity by the patient using a Visual analogue scale (VAS) between T0 and T3. [ Time Frame: 3 months (between T0 and T3 visit) ]

Secondary Outcome Measures :
  1. Variation of serum levels of sColl2-1 (type II collagen degradation) and ultrasensitive CRP (C-reactive protein) biomarkers by specific immunoassays (Enzyme-linked Immunosorbent assay, ELISA). [ Time Frame: 6 months (between T0 and T6 visit) ]
  2. Mean knee pain over the last 24 hours using a visual analogue scale (VAS). [ Time Frame: 6 months (between T0 and T6 visit) ]
  3. Global assessment of disease activity using a visual analogue scale (VAS). [ Time Frame: 6 months (between T0 and T6 visit) ]
  4. Evaluation of Incidence of Emergent Adverse Events (AE), drop-outs and safety issues using blood safety analyses on patients with AE (Tolerance). [ Time Frame: 6 months (between T0 and T6 visit) ]
  5. Count the capsules in investigation kits brought back by the patient. [ Time Frame: 6 months (between T0 and T6 visit) ]
  6. Dosage by UHPLC-MS/MS and monitoring of curcumin blood level to assess patient compliance. [ Time Frame: 6 months (between T0 and T6 visit) ]
  7. Evaluation of Patient's satisfaction by Likert scale. [ Time Frame: 6 months (between T0 and T6 visit) ]
  8. Evaluate the use of rescue treatments i.e. Paracetamol and oral non-steroidal anti-inflammatory drugs (NSAIDs) during the study. [ Time Frame: 6 months (between T0 and T6 visit) ]
  9. Secondary outcome 8: Knee injury Osteoarthritis Outcome Score (KOOS) index and its subscale scores using a self-administered questionnaire. [ Time Frame: 6 months (between T0 and T6 visit) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female between the age of 45 and 80

Exclusion Criteria:

  • Artialis (study coordinator) or Tilman (Sponsor) 's employees
  • Participation to a therapeutic clinical trial in the last 3 months
  • Under guardianship or judicial protection

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): NCT02909621


Locations
Belgium
University Hospital of Liège (CHU-Liège)-Coordinating Center
Liège, Province Of Liege, Belgium, 4000
Sponsors and Collaborators
Tilman S.A.
Artialis

Additional Information:
Responsible Party: Tilman S.A.
ClinicalTrials.gov Identifier: NCT02909621     History of Changes
Other Study ID Numbers: COPRA
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tilman S.A.:
OsteoArthritis; FLEXOFYTOL®; Curcuma; biomarkers

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Turmeric extract
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs