CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 7 enrolled
Drug / intervention
Sodium Benzoate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02111200
NCT02111200N/ACompleted

Comparative Efficacy of Phenylbutyrate vs. Benzoate in Urea Cycle Disorders

Baylor College of Medicine·interventional·Posted Apr 11, 2014·Updated Jan 9, 2018

In Brief

A clinical study evaluating Sodium Benzoate and Sodium Phenylbutyrate for Urea Cycle Disorders, Inborn. Completed, enrolled 7 participants across 1 site.

Detailed Summary

The investigators will study and compare how effectively sodium phenylbutyrate, sodium benzoate, and a combination of the two, help excrete nitrogen in healthy volunteers. Subject participation will require three, separate, four-day study periods at least one week apart. During one study period (also called a treatment arm), subjects will take sodium phenylbutyrate; during another they will take sodium benzoate; during another they will take a combination of the two medications. We expect to find that phenylbutyrate is more effective at removing nitrogen than benzoate or a combination of the two.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 11, 2014
Enrollment StartSep 1, 2014
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 12.2 years ago

Interventions

Sodium Benzoatedrug

Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.

Sodium Phenylbutyratedrug

Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.