| June 6, 2008 |
| June 9, 2008 |
| June 2007 |
| June 2010 (final data collection date for primary outcome measure) |
| Abdominal Pain Scale [ Time Frame: 0, 0.5, 1, 2 months ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00694564 on ClinicalTrials.gov Archive Site |
| Safety [ Time Frame: 0, 0.5, 1, 2 ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| Evaluation of S-Adenosyl Methionine (SAM-e) for Recurrent Abdominal Pain in Children |
| 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 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. |
| |
| Phase I, Phase II |
| Interventional |
| Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Abdominal Pain |
| Drug: S-adenosyl methionine |
| Experimental: This an open-labeled study. All participants will receive SAM-e. |
| |
| |
| Recruiting |
| 30 |
| December 2010 |
| June 2010 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 8 Years to 18 Years |
| No |
|
|
| United States |
| |
| NCT00694564 |
| Jeannie Huang, MD, MPH, University of California, San Diego |
| UCSD060705, IND 75,404 |
| Huang, Jeannie, M.D. |
| Pharmavite |
| Principal Investigator: |
Jeannie Huang, MD, MPH |
University of California, San Diego |
|
|
| Huang, Jeannie, M.D. |
| June 2008 |
