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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

SAMe 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.Check my eligibility

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.See study design

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.

SAMe Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

SAMe Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: S-Adenosyl-L-Methionine (SAMe)Experimental Treatment2 Interventions

Participants receive S-Adenosyl-L-Methionine (SAMe) 400mg capsule orally twice daily for 8 weeks, followed by a 1 week washout period.

Group II: PlaceboPlacebo Group2 Interventions

Participants receive identically appearing 400mg capsule orally twice daily for 8 weeks, followed by a 1 week washout period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor

526 Previous Clinical Trials

2,541,222 Total Patients Enrolled

4 Trials studying Osteoarthritis

649 Patients Enrolled for Osteoarthritis

Scott C Jaynes, MDPrincipal InvestigatorDartmouth-Hitchcock Medical Center

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05363020 — Phase 4

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05363020 — Phase 4

Osteoarthritis Research Study Groups: S-Adenosyl-L-Methionine (SAMe), Placebo

Osteoarthritis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05363020 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 40 or older permitted to enroll in this clinical research?

"This medical investigation is enrolling participants aged over 50 and younger than 75."

Answered by AI

Is there a specific demographic that is eligible to enroll in this medical experiment?

"This clinical trial seeks 40 individuals with hand osteoarthritis aged between 50 and 75. Applicants must meet the following criteria: Objective findings of at least one hand that adheres to American College of Rheumatology (ACR) diagnosis, an active primary care provider at Heater Road Primary Care, a recent office visit in the past 3 years, be currently taking OTC or prescription analgesics and willing to stop their current medication for two weeks prior to study entry, swelling or deformity in 2 out of 10 specified joints—the second/third distal interphalangeal (DIP)of each hand; second/"

Answered by AI

Are individuals currently able to enroll in this investigation?

"According to clinicaltrials.gov, this medical trial has finished patient recruitment; the posting was first made on June 1st 2022 and the latest update was also posted on that same day. Nonetheless, 613 other studies remain open for enrollment at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

S-Asenosyl-L-Methionine vs Placebo for Osteoarthritis of the Hands

Scott C. Jaynes 2022. "S-Asenosyl-L-Methionine vs Placebo for Osteoarthritis of the Hands". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05363020.