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Evaluation of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Huang, Jeannie, M.D.
ClinicalTrials.gov Identifier:
NCT00694564
First received: June 6, 2008
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Abdominal Pain
Drug: S-adenosyl methionine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Open-labeled Trial of S-adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children

Resource links provided by NLM:


Further study details as provided by Huang, Jeannie, M.D.:

Primary Outcome Measures:
  • Wong-Baker FACES Pain Rating Scale [ Time Frame: 0, 2 weeks, 1 month, 2 months ] [ Designated as safety issue: No ]
    We scored the Wong-Baker Pain Rating Scale numerically on a scale of 0 (no pain) to 4 (worst pain).


Secondary Outcome Measures:
  • Safety [ Time Frame: 0, 2 weeks, 1 month, 2 month ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: June 2007
Study Completion Date: July 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
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.
Drug: S-adenosyl methionine
S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily.
Other Names:
  • SAM-e
  • Mood Plus

  Eligibility

Ages Eligible for Study:   8 Years to 22 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694564

Locations
United States, California
University of California, San Diego
San Diego, California, United States, 92103
Sponsors and Collaborators
Huang, Jeannie, M.D.
Investigators
Principal Investigator: Jeannie Huang, MD, MPH University of California, San Diego
  More Information

No publications provided

Responsible Party: Huang, Jeannie, M.D.
ClinicalTrials.gov Identifier: NCT00694564     History of Changes
Other Study ID Numbers: UCSD060705, IND 75,404
Study First Received: June 6, 2008
Results First Received: March 20, 2013
Last Updated: August 28, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Huang, Jeannie, M.D.:
abdominal pain
children

Additional relevant MeSH terms:
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 24, 2014