NCT05363020

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

S-Adenosyl-L-Methionine (SAMe) vs Placebo for Discomfort and Functional Limitations Associated With Osteoarthritis of the Hands: a Pilot Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to demonstrate the feasibility of evaluating SAMe tolerability, analgesic benefits, and daily functional improvement in patients with osteoarthritis of the hands compared to placebo. The secondary objective of this study is to generate preliminary data on discomfort, function, quality of life in patients with osteoarthritis of the hands when taking SAMe compared to placebo.

Detailed description

At week 0, all patients giving written informed consent and meeting eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to SAMe (400mg orally, twice daily) or placebo (400mg, twice daily) for 8 weeks. Followed by a one week wash out period followed by another 8 weeks of SAMe (400mg, twice daily) or placebo (400mg, twice daily) for 8 weeks (whichever was not given during the first 8 week period). Participants will complete weekly surveys during the entire study regarding hand discomfort, functional limitations and side effects

Conditions

• Osteoarthritis Hand

Interventions

Type	Name	Description
DRUG	S-Adenosyl-L-Methionine (Sam-E)	400 mg capsule
DRUG	Placebo	400 mg identically appearing placebo

Timeline

• Start date: 2022-08-17
• Primary completion: 2025-04-11
• Completion: 2025-04-11
• First posted: 2022-05-05
• Last updated: 2025-07-16

Locations

1 site across 1 country: United States