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SAMe for Osteoarthritis (SAMe Trial)

Phase 4

Waitlist Available

Led By Scott C Jaynes, MD

Research Sponsored by Dartmouth-Hitchcock Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weekly for 17 weeks

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing whether SAMe, a supplement, is better than placebo at reducing pain and improving function in people with osteoarthritis of the hands.

Who is the study for?

This trial is for adults over 40 with hand osteoarthritis, who have swelling or deformity in certain joints and are patients within the Dartmouth Health system. They must be willing to stop taking current pain medications two weeks before and during the study. People with artificial joints, other types of arthritis, bipolar disorder, or on certain medications like daily opioids cannot participate.

What is being tested?

The trial is testing if S-Adenosyl-L-Methionine (SAMe) can help relieve pain and improve daily function in people with hand osteoarthritis compared to a placebo. Participants will receive either SAMe or a placebo and their pain levels, functionality, and quality of life will be monitored.

What are the potential side effects?

While specific side effects for this trial aren't listed, SAMe can generally cause gas, vomiting, diarrhea, headache, and mild insomnia. Placebos typically have no active ingredients but can lead to perceived side effects due to expectations.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weekly for 17 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weekly for 17 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly for 17 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the effect of SAMe supplements on hand discomfort relative to placebo, as measured by the change in discomfort scores over time on a visual analog scale

Secondary study objectives

Determine the effect of SAMe supplementation on quality of life measures regarding hand arthritis, as measured by DASH (Disability of Arm, Shoulder and Hand) survey responses done weekly for 17 weeks

Determine tolerability of SAMe supplementation compared to placebo, as measured by a survey of 14 common symptoms one may experience from a supplement