Status:
COMPLETED
S-Asenosyl-L-Methionine vs Placebo for Osteoarthritis of the Hands
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Conditions:
Osteoarthritis Hand
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief 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...
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 or...
Eligibility Criteria
Inclusion
- Current primary care provider within the Dartmouth Health system
- Office visit at Dartmouth Health in the past 3 years
- Participants must be 40 or older at the time of signing the informed consent
- Participants have discomfort or functional limitations of one or both hands AND either:
- Objective findings of at least one hand meeting diagnostic criteria based on the American College of Rheumatology (ACR)\* or
- Existing radiographic evidence of osteoarthritis as judged by a radiologist
- Patients taking OTC or prescription analgesics who are willing to stop their current analgesics for two weeks prior to study entry and remain off those medications over the course of the study
- \*Objective inclusion criteria (see poster schematic)
- Swelling or deformity of 2 of the following ten joints: the 2nd and 3rd distal interphalangeal (DIP) of each hand, the 2nd and 3rd proximal interphalangeal (PIP) of each hand, and the 1st carpometacarpal joints of both hands.
Exclusion
- Patients taking prescription medications other than NSAIDs for their OA who are unable to stop their medication
- Patients with diagnoses of arthritis from conditions other than OA
- Patients whose symptomatic joint is an artificial joint
- Patients with Bipolar Disorder
- Patients taking any of the following medications at study entry OR starting any of these medications during the study period:
- daily opioids (including tramadol or buprenorphine)
- gabapentin or pregabalin
- prednisone
- Prescription NSAIDs that they are unable to stop or topical diclofenac
- SNRI drugs (Effexor, Cymbalta, Fetzima, Pristiq)
- The participant has a condition or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study
Key Trial Info
Start Date :
August 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05363020
Start Date
August 17 2022
End Date
April 11 2025
Last Update
July 16 2025
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756