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NCT05363020 | Active, not recruiting | Osteoarthritis Hand

S-Adenosyl-L-Methionine vs Placebo for Osteoarthritis of the Hands
Sponsor:

Dartmouth-Hitchcock Medical Center

Information provided by (Responsible Party):

Scott C. Jaynes

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 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.

Condition or disease

Osteoarthritis Hand

Intervention/treatment

S-Adenosyl-L-Methionine (Sam-E)

Placebo

Phase

Phase 4

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}}

Study Type : Interventional
Estimated Enrollment : 40 participants
Masking : Triple
Primary Purpose : Supportive Care
Official Title : S-Adenosyl-L-Methionine (SAMe) vs Placebo for Discomfort and Functional Limitations Associated With Osteoarthritis of the Hands: a Pilot Study
Actual Study Start Date : August 17, 2022
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : August 1, 2024
Arm Intervention/treatment

Experimental: S-Adenosyl-L-Methionine (SAMe)

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

Drug: S-Adenosyl-L-Methionine (Sam-E)

Drug: Placebo

Placebo Comparator: Placebo

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

Drug: S-Adenosyl-L-Methionine (Sam-E)

Drug: Placebo
Ages Eligible for Study: 40 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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 Criteria
    • 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
S-Adenosyl-L-Methionine vs Placebo for Osteoarthritis of the Hands

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

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Locations

Not yet recruiting

United States, New Hampshire

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756