Evaluation 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.
|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|
- 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).
- Safety [ Time Frame: 0, 2 weeks, 1 month, 2 month ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2007|
|Study Completion Date:||July 2012|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00694564
|United States, California|
|University of California, San Diego|
|San Diego, California, United States, 92103|
|Principal Investigator:||Jeannie Huang, MD, MPH||University of California, San Diego|