Abdominal PainNCT00694564
Evaluation of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children
A study testing S-adenosyl methionine in people with Abdominal Pain, run by Huang, Jeannie, M.D. at 1 site in United States.
Trial summary
This pilot study will investigate the efficacy of SAM-e for the treatment of recurrent abdominal pain in children. This will be an open-labeled study and all participants will receive SAM-e therapy. Read more about this study
- Who is it for?
- Ages 8 to 22 years
- Conditions the study is for
- Abdominal Pain
- What is being tested?
- S-adenosyl methionine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jul 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 8 to 22 years old
- Diagnosed with RAP as verified by a physician, and having at least twice weekly episodes of abdominal pain which cause the patient to withdraw from normal activities.
- At least one month trial on a high fiber diet without resolution of abdominal pain.
- Ambulatory
Who cannot join
- Focal abdominal pain by history or physical exam, unless a negative (including endoscopic) evaluation has been performed
- Current diagnosis of inflammatory bowel disease, pancreatitis (acute or recurrent), peptic ulcer disease, gastrointestinal infection (unresolved), or ongoing gastrointestinal inflammation.
- Current or recent (within the past year) pregnancy and/or current breastfeeding.
- Current diagnosis of nephropathy or genitourinary disease.
- Blood in stools or emesis (EXCEPTION: blood in the stool secondary to hemorrhoids is not an exclusion criterion).
- Unintentional loss of over 10% body weight over the past 3 months or weight < 100% ideal body weight.
Show all 14Show fewer
- Recurrent fevers (T>100F) at least once a week or with abdominal pain episodes.
- Recurrent dehydration with abdominal pain episodes requiring intravenous rehydration.
- Current personal diagnosis of depression or report of suicidality, mania or bipolar disorder.
- Family history of mania or bipolar disorder.
- Current use of opiates or other prescription pain medications and/or refusal to remain off opiate/prescription pain medications during the study period.
- Currently receiving additional therapies besides diet for recurrent abdominal pain and/or refusal to remain off such therapies during the study period, including but not limited to anticholinergic medications, antidepressant medications, biofeedback therapy, cognitive behavioral therapy.
- Hypersensitivity to SAM-e.
- Inability of child to provide assent and/or inability of parent/custodian to give consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92103
About this study
Official title: A Pilot Open-labeled Trial of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children
This pilot study will investigate the efficacy of SAM-e for the treatment of recurrent abdominal pain in children. This will be an open-labeled study and all participants will receive SAM-e therapy. Given that SAM-e has been demonstrated to improve symptoms of depression and pain with minimal side effects as compared to other antidepressant therapy, we hypothesize that SAM-e will reduce pain symptoms among children with recurrent abdominal pain.
- Conditions
- Abdominal Pain
- Being tested
- S-adenosyl methionine
- Keywords
- abdominal pain, children
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-adenosyl methionineDrug
Also called SAM-e, Mood Plus
S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | This an open-labeled study. All participants will be part of the treatment group and receive SAM-e. S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily. Receives: Drug: S-adenosyl methionine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker FACES Pain Rating Scale
We scored the Wong-Baker Pain Rating Scale numerically on a scale of 0 (no pain) to 4 (worst pain).
Measured: 0, 2 weeks, 1 month, 2 months
Secondary outcomes (1)
Safety
Assessments of liver transaminases and alkaline phosphatasewere performed at baseline, 2 weeks, 1 month and 2 months. Depression and mania were assessed weekly.
Measured: 0, 2 weeks, 1 month, 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startJun 2007
- Primary completionMar 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huang, Jeannie, M.D.
- Responsible party
- Sponsor
- Investigators
- Jeannie Huang, MD, MPH, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694564
- Sponsor's protocol ID
- UCSD060705
- Other IDs
- IND 75,404
- Status last verified
- Jan 2016
- First submitted
- 6 Jun 2008
- Last updated
- 16 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Open-labeled Trial of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children
- ClinicalTrials.gov ID
- NCT00694564
- Acronym / sponsor ID
- UCSD060705
- Conditions
- Abdominal Pain
- Keywords
- abdominal pain, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Huang, Jeannie, M.D.
- Study start
- Jun 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 10 Jun 2008 (estimated)
- Results
- Posted 13 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study will investigate the efficacy of SAM-e for the treatment of recurrent abdominal pain in children. This will be an open-labeled study and all participants will receive SAM-e therapy. Given that SAM-e has been demonstrated to improve symptoms of depression and pain with minimal side effects as compared to other antidepressant therapy, we hypothesize that SAM-e will reduce pain symptoms among children with recurrent abdominal pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: S-adenosyl methionineThis an open-labeled study. All participants will be part of the treatment group and receive SAM-e. S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily. |
Who may qualify
- Ages
- 8 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 8 to 22 years old
- Diagnosed with RAP as verified by a physician, and having at least twice weekly episodes of abdominal pain which cause the patient to withdraw from normal activities.
- At least one month trial on a high fiber diet without resolution of abdominal pain.
- Ambulatory
Key exclusion criteria (14 listed)
- Focal abdominal pain by history or physical exam, unless a negative (including endoscopic) evaluation has been performed
- Current diagnosis of inflammatory bowel disease, pancreatitis (acute or recurrent), peptic ulcer disease, gastrointestinal infection (unresolved), or ongoing gastrointestinal inflammation.
- Current or recent (within the past year) pregnancy and/or current breastfeeding.
- Current diagnosis of nephropathy or genitourinary disease.
- Blood in stools or emesis (EXCEPTION: blood in the stool secondary to hemorrhoids is not an exclusion criterion).
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 methionineAlso: SAM-e, Mood PlusS-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily. | Drug | Treatment |
Primary outcome
Wong-Baker FACES Pain Rating Scale
Time frame: 0, 2 weeks, 1 month, 2 months
We scored the Wong-Baker Pain Rating Scale numerically on a scale of 0 (no pain) to 4 (worst pain).
1 secondary outcome
Safety
Time frame: 0, 2 weeks, 1 month, 2 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeannie Huang, MD, MPH principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S-adenosyl methionine in people with Abdominal Pain, run by Huang, Jeannie, M.D. 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 4 inclusion and 14 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 Mar 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Wong-Baker FACES Pain Rating Scale (time frame: 0, 2 weeks, 1 month, 2 months). 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 Mar 2018.