Osteoarthritis HandPhase 4SAMeNCT05363020
S-Asenosyl-L-Methionine vs Placebo for Osteoarthritis of the Hands
A Phase 4 study testing S-Adenosyl-L-Methionine (Sam-E) in people with Osteoarthritis Hand, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis Hand
- What is being tested?
- S-Adenosyl-L-Methionine (Sam-E)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2022to 11 Apr 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: S-Adenosyl-L-Methionine (SAMe) vs Placebo for Discomfort and Functional Limitations Associated With Osteoarthritis of the Hands: a Pilot Study
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.
Read the 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
- Being tested
- S-Adenosyl-L-Methionine (Sam-E), Placebo
- Keywords
- SAMe, S-Adenosyl-L-Methionine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-Adenosyl-L-Methionine (Sam-E)Drug
400 mg capsule
PlaceboDrug
400 mg identically appearing placebo
| Study group | Role | What they receive |
|---|---|---|
| S-Adenosyl-L-Methionine (SAMe) | Experimental | Participants receive S-Adenosyl-L-Methionine (SAMe) 400mg capsule orally twice daily for 8 weeks, followed by a 1 week washout period. Receives: Drug: S-Adenosyl-L-Methionine (Sam-E); Drug: Placebo |
| Placebo | Placebo comparator | Participants receive identically appearing 400mg capsule orally twice daily for 8 weeks, followed by a 1 week washout period. Receives: Drug: S-Adenosyl-L-Methionine (Sam-E); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Scores range from 0-10, 0 being no discomfort and 10 being maximum discomfort
Measured: Weekly for 17 weeks
Secondary outcomes (2)
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
Survey using descriptors of disability and function ranging from no disability to complete disability with 3 other levels of disability in between done weekly for 17 weeks
Measured: 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
14 symptoms queried for occurrence over the week ranging from "Not at All" to "Very Much" with three additional options in between
Measured: Weekly for 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start17 Aug 2022
- Primary completion11 Apr 2025
- Study completion11 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis HandStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott C. Jaynes, Dartmouth-Hitchcock Medical Center
- Investigators
- Scott C Jaynes, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05363020
- Sponsor's protocol ID
- STUDY02001354
- Acronym
- SAMe
- Status last verified
- Jul 2025
- First submitted
- 2 May 2022
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S-Adenosyl-L-Methionine (SAMe) vs Placebo for Discomfort and Functional Limitations Associated With Osteoarthritis of the Hands: a Pilot Study
- ClinicalTrials.gov ID
- NCT05363020
- Acronym / sponsor ID
- SAMe / STUDY02001354
- Conditions
- Osteoarthritis Hand
- Keywords
- SAMe, S-Adenosyl-L-Methionine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 11 Apr 2025 (actual)
- Study completion
- 11 Apr 2025 (actual)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-Adenosyl-L-Methionine (SAMe) | Experimental | Drug: S-Adenosyl-L-Methionine (Sam-E), Drug: PlaceboParticipants receive S-Adenosyl-L-Methionine (SAMe) 400mg capsule orally twice daily for 8 weeks, followed by a 1 week washout period. |
| Placebo | Placebo comparator | Drug: S-Adenosyl-L-Methionine (Sam-E), Drug: PlaceboParticipants receive identically appearing 400mg capsule orally twice daily for 8 weeks, followed by a 1 week washout period. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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
Key exclusion criteria (11 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-Adenosyl-L-Methionine (Sam-E)400 mg capsule | Drug | Placebo, S-Adenosyl-L-Methionine (SAMe) |
| Placebo400 mg identically appearing placebo | Drug | Placebo, S-Adenosyl-L-Methionine (SAMe) |
Primary outcome
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
Time frame: Weekly for 17 weeks
Scores range from 0-10, 0 being no discomfort and 10 being maximum discomfort
2 secondary outcomes
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
Time frame: 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
Time frame: Weekly for 17 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott C Jaynes, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing S-Adenosyl-L-Methionine (Sam-E) in people with Osteoarthritis Hand, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Weekly for 17 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.