NCT01836757

Brief Summary

To delineate the effect of MSM on osteoarthritis

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 22, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

April 22, 2013

Status Verified

April 1, 2013

Enrollment Period

1 year

First QC Date

March 13, 2013

Last Update Submit

April 17, 2013

Conditions

Keywords

osteoarthritisCAM treatmentsMSM

Outcome Measures

Primary Outcomes (1)

  • Number of participants with improved Mobility

    Randomized, double-blind, placebo-controlled trial including an intervention and a placebo group. One hundred men and women, with hip and/or knee OA were divided in 2 groups. Intervention was either MSM 3 gr twice a day for 26 weeks (6 gr/day total) for one group and placebo for the other. Outcomes measured were the Western Ontario and McMaster University Osteoarthritis Index visual analogue scale (WOMAC)

    26 weeks

Secondary Outcomes (1)

  • Pain Scores on the Visual Analog Scale

    26 weeks

Study Arms (2)

MSM group

EXPERIMENTAL

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

Drug: MethylSulfonylMethane (MSM)

Placebo Group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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

MSM group
Placebo Group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

G. Papanikolaou Hospital

Thessaloniki, Thessaloniki, 57010, Greece

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Interventions

dimethyl sulfone

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Thomas Pagonis, MD, PhD

    Aristotle's University of Thessaloniki

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Pagonis, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopaedic Surgeon

Study Record Dates

First Submitted

March 13, 2013

First Posted

April 22, 2013

Study Start

September 1, 2012

Primary Completion

September 1, 2013

Study Completion

October 1, 2013

Last Updated

April 22, 2013

Record last verified: 2013-04

Locations