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| ID | Type | Description | Link |
|---|---|---|---|
| IND 75,404 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-adenosyl methionine | Drug | S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wong-Baker FACES Pain Rating Scale | We scored the Wong-Baker Pain Rating Scale numerically on a scale of 0 (no pain) to 4 (worst pain). | 0, 2 weeks, 1 month, 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Assessments of liver transaminases and alkaline phosphatasewere performed at baseline, 2 weeks, 1 month and 2 months. Depression and mania were assessed weekly. | 0, 2 weeks, 1 month, 2 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeannie Huang, MD, MPH | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | San Diego | California | 92103 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SAM-e | This an open-labeled study. All participants received SAM-e. S-adenosyl methionine : All participants received oral SAM-e which was initiated at a dose of 200 mg daily and escalated by 200 mg every week to a maximum dose of 1400 mg daily if patients did not report significant resolution of abdominal pain (defined as reduction in reported pain and to a maximum frequency of once weekly). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sam-e (Treatment) | This an open-labeled study. All participants will be part of the treatment group and receive SAM-e. S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Wong-Baker FACES Pain Rating Scale | We scored the Wong-Baker Pain Rating Scale numerically on a scale of 0 (no pain) to 4 (worst pain). | Posted | Mean | Standard Deviation | units on a scale | 0, 2 weeks, 1 month, 2 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sam-e (Treatment) | This an open-labeled study. All participants will be part of the treatment group and receive SAM-e. 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headaches | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeannie Huang | UC San Diego | 858-576-1700 | 7322 | jshuang@ucsd.edu |
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| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012436 | S-Adenosylmethionine |
| ID | Term |
|---|---|
| D008715 | Methionine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Safety | Assessments of liver transaminases and alkaline phosphatasewere performed at baseline, 2 weeks, 1 month and 2 months. Depression and mania were assessed weekly. | Not Posted | 0, 2 weeks, 1 month, 2 month | Participants |
| 0 |
| 8 |
| 7 |
| 8 |
| Alkaline Phosphatase Decrease | Hepatobiliary disorders |
|
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| D012817 | Signs and Symptoms, Digestive |
| D000241 |
| Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |