Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:14 AM
Ignite Modification Date:
2025-12-25 @ 3:14 AM
NCT ID:
NCT00345605
Eligibility Criteria:
Inclusion Criteria:
* Has confirmed diagnosis of ASA by amino acid or enzyme assay
* Has a history of adequate compliance to the diet and treatment
* Able to take oral or G-tube medication
* Able to perform 24 hour urine collection
* Agrees to travel to Baylor College of Medicine
* If female, of child bearing potential, and sexually active, agrees to use an acceptable method of birth control
* Greater than 5 years of age
Exclusion Criteria:
* Has a history of congestive heart failure, severe renal insufficiency, or any condition that causes sodium retention or edema
* Currently taking Probenecid, Haloperidol, Valproate or oral corticosteroids
* Pregnant or lactating
* Currently being treated for an acute illness
* Has co-morbid associations causing difficulties in the detection of hyperammonemic episodes, liver damage, or difficulties in the diet compliance
* Has known hypersensitivity to sodium phenylbutyrate
* Has taken any experimental medication within the last 30 days
* Has renal insufficiency with creatinine greater than 1.5 mg/dl at screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Study:
NCT00345605
Study Brief:
Protocol Section:
NCT00345605