NCT01909037

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for early_phase_1 knee-osteoarthritis

Timeline
Completed

Started Mar 2012

Shorter than P25 for early_phase_1 knee-osteoarthritis

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

March 1, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 26, 2013

Completed
Last Updated

June 23, 2015

Status Verified

July 1, 2013

Enrollment Period

9 months

First QC Date

July 18, 2013

Last Update Submit

June 22, 2015

Conditions

Knee Osteoarthritis

Keywords

osteoarthritiscurcuminbiomarkerpain

Outcome Measures

Primary Outcomes (1)

  • Serum levels of biomarkers of cartilage metabolism and inflammation

    Change from baseline of serum levels of biomarkers

    84 days

Secondary Outcomes (1)

  • Pain and the global patient assessment of disease activity using a Visual Analog Scale (VAS)

    84 days

Study Arms (1)

Flexofytol (bio-optimized curcumin)

EXPERIMENTAL
Dietary Supplement: Flexofytol (bio-optimized curcumin)

Interventions

Flexofytol (bio-optimized curcumin)DIETARY_SUPPLEMENT

2x3 caps/day (before breakfast and in the evening) for 3 months

Flexofytol (bio-optimized curcumin)

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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,
  • 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...),
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Citadelle Hospital

Liège, 4000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 24886572DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisPain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Caroline Castermans, MD

    Citadelle Hospital of Liege

    PRINCIPAL INVESTIGATOR

  • Yvan Dierckxsens

    Tilman S.A.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2013

First Posted

July 26, 2013

Study Start

March 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 23, 2015

Record last verified: 2013-07

Locations

BE(1)