Advertisement

Topics

Evaluation of FLEXOFYTOL® Versus PLACEBO

2016-09-21 20:23:22 | BioPortfolio

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).

The product FLEXOFYTOL® is a food supplement based on turmeric extract, with standardised curcumin content. This product is intended to maintain and relieve the joints of those with osteoarthritis. 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.

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Conditions

Osteoarthritis

Intervention

FLEXOFYTOL®, PLACEBO

Location

University Hospital of Liège (CHU-Liège)-Coordinating Center
Liège
Province of Liege
Belgium
4000

Status

Recruiting

Source

Tilman S.A.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-09-21T20:23:22-0400

Clinical Trials [536 Associated Clinical Trials listed on BioPortfolio]

Blocking Extracellular Galectin-3 in Patients With Osteoarthritis

The proposed study is a pilot, double-blind, randomized clinical trial comparing galectin-3 inhibition with MCP to placebo for the treatment of knee osteoarthritis.

Pain Management in Osteoarthritis Using the Centrally Acting Analgesics Duloxetine and Pregabalin

Osteoarthritis is the most common form of arthritis worldwide. Specifically, osteoarthritis of the hands affects millions of people and is a major cause of hand disability and pain. Despit...

Chondromodulating Effect of Diacerein in Osteoarthritis of the Hip

We carried out a 3 years, randomized, double-blind, placebo-controlled, multicenter clinical trial in patients with hip osteoarthritis in order to: - evaluate the ability of diacerein,...

Treatment for Patients With Osteoarthritis (OA)

The purpose of this study is to evaluate the clinical benefit (change in Western Ontario and McMaster University Osteoarthritis Index [WOMAC] pain score) of AMG 108 (300 mg subcutaneously ...

A Dose-Ranging Study Of Valdecoxib 5 Mg, 10 Mg, And 20 Mg Once Daily Versus Placebo In Patients With Osteoarthritis Of The Knee (Japan)

To determine the therapeutic dose range of valdecoxib by comparing the efficacy of three dosing regimens (5 mg, 10 mg and 20 mg once daily) with placebo for relief of the signs and symptom...

PubMed Articles [1474 Associated PubMed Articles listed on BioPortfolio]

Short-term placebo response in trials of patients with symptomatic osteoarthritis: differences between hip and knee.

In placebo-controlled RCT of symptomatic treatment in osteoarthritis (OA) the extent of pain reduction is heterogeneous, the pooled effect size rather small. Pain reduction is typically higher in knee...

The Effects of Licorice Flavonoid Oil on Increasing Muscle Mass: A Randomized, Double-Blind, Placebo-Controlled Trial.

The current study evaluated the effects of licorice flavonoid oil (LFO) on increasing the muscle mass of elderly populations using a randomized, double-blind, placebo-controlled study. Fifty participa...

Magnetic resonance therapy for knee osteoarthritis: a randomized, double blind placebo controlled trial.

To investigate efficacy of MRT in knee osteoarthritis (OA).

Efficacy and Safety of Celecoxib Therapy in Osteoarthritis: A Meta-Analysis of Randomized Controlled Trials.

Osteoarthritis (OA) is the most common form of arthritis in older individuals and is among the most prevalent and disabling chronic conditions worldwide.We conducted a meta-analysis to determine the e...

Topical capsaicin for pain in osteoarthritis: A literature review.

Osteoarthritis is the most common joint disorder worldwide. The predominant symptom, pain, is usually treated with acetaminophen or oral non-steroidal anti-inflammatory drugs, although they are associ...

Medical and Biotech [MESH] Definitions

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

An IBUPROFEN-type anti-inflammatory analgesic and antipyretic. It is used in the treatment of rheumatoid arthritis and osteoarthritis.

Viscoelastic solutions that are injected into JOINTS in order to alleviate symptoms of joint-related disorders such as OSTEOARTHRITIS.

A condition caused by degenerative arthritis (see OSTEOARTHRITIS) of the METATARSOPHALANGEAL JOINT of the great toe and characterized by pain and limited dorsiflexion, but relatively unrestricted plantar flexion.

More From BioPortfolio on "Evaluation of FLEXOFYTOL® Versus PLACEBO"

Quick Search
Advertisement
 

Relevant Topics

Joint Disorders
A joint is where two or more bones come together, like the knee, hip, elbow, or shoulder. Joints can be damaged by many types of injuries or diseases, including Arthritis - inflammation of a joint causes pain, stiffness, and swelling with ...

Food
Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is ingested by an organism ...


Searches Linking to this Trial