Effect of Methyl-Sulphonyl-Methane on Osteoarthritis and Cartilage

NCT ID: NCT01836757

Last Updated: 2013-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-10-31

Brief Summary

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To delineate the effect of MSM on osteoarthritis

Detailed Description

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Objective: To delineate the effect of MSM on osteoarthritis of large joints. Design: Randomized, double-blind, placebo-controlled trial including an intervention and a placebo group. One hundred men and women, with hip and/or knee OA to be divided in 2 groups. Intervention is either MSM 3 gr twice a day for 26 weeks (6 gr/day total) for one group and placebo for the other. Outcomes measured are the Western Ontario and McMaster University Osteoarthritis Index visual analogue scale (WOMAC), patient and physician assessments and SF-36 (overall health-related quality of life).

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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MSM group

Intervention is MSM 3 gr twice a day for 26 weeks (6 gr/day total)

Group Type EXPERIMENTAL

MethylSulfonylMethane (MSM)

Intervention Type DRUG

Intervention is MSM 3 gr twice a day for 26 weeks (6 gr/day total)

Placebo Group

Placebo 3 gr twice a day for 26 weeks (6 gr/day total)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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MethylSulfonylMethane (MSM)

Intervention is MSM 3 gr twice a day for 26 weeks (6 gr/day total)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Knee and hip OA
* men and women \>45 years of age

Exclusion Criteria

* any other type of arthritis
* chronic pain syndrome
* arthroscopic surgery in the past 8 months
* intra-articular corticosteroidsin the past 8 months
* hyaluronic acid injections in the past 8 months
* narcotic pain killers use
* renal or hepatic disease
* body mass index (BMI) \>45 kg/m2
* cancer
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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G.Papanikolaou Research Group

OTHER

Sponsor Role lead

Responsible Party

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Thomas Pagonis

Orthopaedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Pagonis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Aristotle's University of Thessaloniki

Locations

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G. Papanikolaou Hospital

Thessaloniki, Thessaloniki, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Thomas Pagonis, MD, PhD

Role: CONTACT

00306980488686

Facility Contacts

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Panagiotis Givisis, MD, PhD

Role: primary

00306945264010

Other Identifiers

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msm2012

Identifier Type: -

Identifier Source: org_study_id

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