Evaluation of S-Adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children - Full Text View

Sponsor:	Huang, Jeannie, M.D.
Collaborator:	Pharmavite
Information provided by:	Huang, Jeannie, M.D.
ClinicalTrials.gov Identifier:	NCT00694564

Purpose

This pilot study will investigate the efficacy of SAM-e for the treatment of recurrent abdominal pain in a total of 30 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 I Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Pilot Open-Labeled Trial of S-Adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children

Resource links provided by NLM:

MedlinePlus related topics: Abdominal Pain

Drug Information available for: Methionine S-Adenosylmethionine

U.S. FDA Resources

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

Primary Outcome Measures:

Abdominal Pain Scale [ Time Frame: 0, 0.5, 1, 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Time Frame: 0, 0.5, 1, 2 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment: Experimental This an open-labeled study. All participants will receive SAM-e.	Drug: S-adenosyl methionine S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily.

Eligibility

Ages Eligible for Study:	8 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

8 to 18 years old
Diagnosed with RAP as verified by a physician, and having at least every other day 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

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

Contacts

Contact: Jeannie Huang, MD, MPH	619-543-7544	jshuang@ucsd.edu
Contact: Lillian Choi, MD	619-543-7544	ljchoi@ucsd.edu

Locations

United States, California
University of California, San Diego	Recruiting
San Diego, California, United States, 92103
Principal Investigator: Jeannie Huang, MD, MPH

Sponsors and Collaborators

Huang, Jeannie, M.D.

Pharmavite

Investigators

Principal Investigator:

Jeannie Huang, MD, MPH

University of California, San Diego

More Information

No publications provided

Responsible Party:	University of California, San Diego ( Jeannie Huang, MD, MPH )
Study ID Numbers:	UCSD060705, IND 75,404
Study First Received:	June 6, 2008
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00694564 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Huang, Jeannie, M.D.:

abdominal pain
children

Additional relevant MeSH terms:

Signs and Symptoms
Signs and Symptoms, Digestive
Abdominal Pain
Pain

ClinicalTrials.gov processed this record on November 22, 2009