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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Early Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Flexofytol (bio-optimized curcumin)
Sponsored by
Tilman S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring osteoarthritis, curcumin, biomarker, pain

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Citadelle Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Flexofytol (bio-optimized curcumin)

Arm Description

Outcomes

Primary Outcome Measures

Serum levels of biomarkers of cartilage metabolism and inflammation
Change from baseline of serum levels of biomarkers

Secondary Outcome Measures

Pain and the global patient assessment of disease activity using a Visual Analog Scale (VAS)
Change from baseline of the mean pain over the last 24 hours and of the global assessment of disease activity by the patient

Full Information

First Posted
July 18, 2013
Last Updated
June 22, 2015
Sponsor
Tilman S.A.
Collaborators
Bioxtract SA
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1. Study Identification

Unique Protocol Identification Number
NCT01909037
Brief Title
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

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tilman S.A.
Collaborators
Bioxtract SA

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
osteoarthritis, curcumin, biomarker, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flexofytol (bio-optimized curcumin)
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Flexofytol (bio-optimized curcumin)
Intervention Description
2x3 caps/day (before breakfast and in the evening) for 3 months
Primary Outcome Measure Information:
Title
Serum levels of biomarkers of cartilage metabolism and inflammation
Description
Change from baseline of serum levels of biomarkers
Time Frame
84 days
Secondary Outcome Measure Information:
Title
Pain and the global patient assessment of disease activity using a Visual Analog Scale (VAS)
Description
Change from baseline of the mean pain over the last 24 hours and of the global assessment of disease activity by the patient
Time Frame
84 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Castermans, MD
Organizational Affiliation
Citadelle Hospital of Liege
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yvan Dierckxsens
Organizational Affiliation
Tilman S.A.
Official's Role
Study Director
Facility Information:
Facility Name
Citadelle Hospital
City
Liege
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
24886572
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.
Results Reference
derived

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

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