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Sponsors and Collaborators: |
Huang, Jeannie, M.D. Pharmavite |
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Information provided by: | Huang, Jeannie, M.D. |
ClinicalTrials.gov Identifier: | NCT00694564 |
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 |
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.
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Drug: S-adenosyl methionine
S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily.
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Ages Eligible for Study: | 8 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jeannie Huang, MD, MPH | 619-543-7544 | jshuang@ucsd.edu |
Contact: Lillian Choi, MD | 619-543-7544 | ljchoi@ucsd.edu |
United States, California | |
University of California, San Diego | Recruiting |
San Diego, California, United States, 92103 | |
Principal Investigator: Jeannie Huang, MD, MPH |
Principal Investigator: | Jeannie Huang, MD, MPH | University of California, San Diego |
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 |
Health Authority: | United States: Food and Drug Administration |
abdominal pain children |
Signs and Symptoms Signs and Symptoms, Digestive Abdominal Pain Pain Recurrence |