NCT02909621

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

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

May 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

3.2 years

First QC Date

September 13, 2016

Last Update Submit

November 2, 2017

Conditions

Osteoarthritis

Keywords

OsteoArthritis; FLEXOFYTOL®; Curcuma; biomarkers

Outcome Measures

Primary Outcomes (2)

  • Variation of serum levels of sColl2-1 biomarker between T0 and T3 by specific immunoassays (Enzyme-linked Immunosorbent assay, ELISA).

    3 months (between T0 and T3 visit)

  • Variation of Global assessment of disease activity by the patient using a Visual analogue scale (VAS) between T0 and T3.

    3 months (between T0 and T3 visit)

Secondary Outcomes (9)

  • 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).

    6 months (between T0 and T6 visit)

  • Mean knee pain over the last 24 hours using a visual analogue scale (VAS).

    6 months (between T0 and T6 visit)

  • Global assessment of disease activity using a visual analogue scale (VAS).

    6 months (between T0 and T6 visit)

  • Evaluation of Incidence of Emergent Adverse Events (AE), drop-outs and safety issues using blood safety analyses on patients with AE (Tolerance).

    6 months (between T0 and T6 visit)

  • Count the capsules in investigation kits brought back by the patient.

    6 months (between T0 and T6 visit)

  • +4 more secondary outcomes

Study Arms (3)

Group A

ACTIVE COMPARATOR

Group A: FLEXOFYTOL® high dosage

Dietary Supplement: FLEXOFYTOL®

Group B

ACTIVE COMPARATOR

Group B: FLEXOFYTOL® low dosage

Dietary Supplement: FLEXOFYTOL®

Group C

PLACEBO COMPARATOR

Group C: PLACEBO

Other: PLACEBO

Interventions

FLEXOFYTOL®DIETARY_SUPPLEMENT

The product FLEXOFYTOL® is bio-optimized curcumin.

Also known as: curcuma extract
Group AGroup B
PLACEBOOTHER
Group C

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female between the age of 45 and 80

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Liège (CHU-Liège)-Coordinating Center

Liège, Province of Liege, 4000, Belgium

Location

Related Publications (1)

  • Henrotin Y, Malaise M, Wittoek R, de Vlam K, Brasseur JP, Luyten FP, Jiangang Q, Van den Berghe M, Uhoda R, Bentin J, De Vroey T, Erpicum L, Donneau AF, Dierckxsens Y. Bio-optimized Curcuma longa extract is efficient on knee osteoarthritis pain: a double-blind multicenter randomized placebo controlled three-arm study. Arthritis Res Ther. 2019 Jul 27;21(1):179. doi: 10.1186/s13075-019-1960-5.

    PMID: 31351488DERIVED

Related Links

MeSH Terms

Conditions

Osteoarthritis

Interventions

turmeric extract

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 21, 2016

Study Start

May 1, 2014

Primary Completion

July 1, 2017

Study Completion

November 1, 2017

Last Updated

November 6, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)