OsteoarthritisPhase 1msmNCT01836757
Effect of Methyl-Sulphonyl-Methane on Osteoarthritis and Cartilage
A Phase 1 study testing MethylSulfonylMethane (MSM) in people with Osteoarthritis, run by G.Papanikolaou Research Group at 1 site in Greece.
Trial summary
To delineate the effect of MSM on osteoarthritis Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- MethylSulfonylMethane (MSM)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- Sep 2012to Oct 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee and hip OA
- men and women >45 years of age
Who cannot join
- 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
Show all 9Show fewer
- renal or hepatic disease
- body mass index (BMI) >45 kg/m2
- cancer
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
G. Papanikolaou Hospital
Thessaloniki, Thessaloniki, 57010
Panagiotis Givisis, MD, PhD, 00306945264010
Thomas Pagonis, MD, PhD
About this study
Official title: The Effect of Methyl-Sulphonyl-Methane on Osteoarthritis and Joint Cartilage Associated With the Degeneration of the Chondrocyte
To delineate the effect of MSM on osteoarthritis
Read the detailed description
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
- Osteoarthritis
- Being tested
- MethylSulfonylMethane (MSM), Placebo
- Keywords
- osteoarthritis, CAM treatments, MSM
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylSulfonylMethane (MSM)Drug
Intervention is MSM 3 gr twice a day for 26 weeks (6 gr/day total)
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| MSM group | Experimental | Intervention is MSM 3 gr twice a day for 26 weeks (6 gr/day total) Receives: Drug: MethylSulfonylMethane (MSM) |
| Placebo Group | Placebo comparator | Placebo 3 gr twice a day for 26 weeks (6 gr/day total) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 26 weeks
Secondary outcomes (1)
Pain Scores on the Visual Analog Scale
On the same two groups (MSM and Placebo)we measured the improvement of quality of life through pain relief as measured by use of SF-36 (overall health-related quality of life)
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startSep 2012
- Primary completionSep 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G.Papanikolaou Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Pagonis, G.Papanikolaou Research Group
- Investigators
- Thomas Pagonis, MD, PhD, Principal investigator, Aristotle's University of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836757
- Sponsor's protocol ID
- msm2012
- Acronym
- msm
- Status last verified
- Apr 2013
- First submitted
- 13 Mar 2013
- Last updated
- 22 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Methyl-Sulphonyl-Methane on Osteoarthritis and Joint Cartilage Associated With the Degeneration of the Chondrocyte
- ClinicalTrials.gov ID
- NCT01836757
- Acronym / sponsor ID
- msm / msm2012
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, CAM treatments, MSM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- G.Papanikolaou Research GroupUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 22 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To delineate the effect of MSM on osteoarthritis
Detailed description
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSM group | Experimental | Drug: MethylSulfonylMethane (MSM)Intervention is MSM 3 gr twice a day for 26 weeks (6 gr/day total) |
| Placebo Group | Placebo comparator | Drug: PlaceboPlacebo 3 gr twice a day for 26 weeks (6 gr/day total) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Knee and hip OA
- men and women >45 years of age
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylSulfonylMethane (MSM)Intervention is MSM 3 gr twice a day for 26 weeks (6 gr/day total) | Drug | MSM group |
| Placebo | Drug | Placebo Group |
Primary outcome
Number of participants with improved Mobility
Time frame: 26 weeks
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)
1 secondary outcome
Pain Scores on the Visual Analog Scale
Time frame: 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Pagonis, MD, PhD principal investigator
Aristotle's University of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MethylSulfonylMethane (MSM) in people with Osteoarthritis, run by G.Papanikolaou Research Group at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Pagonis, MD, PhD (00306980488686, iatros1@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with improved Mobility (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2013.