NCT02111200

Comparative Efficacy of Phenylbutyrate (PBA) vs. Benzoate in Urea Cycle Disorders

Comparative Efficacy of Phenylbutyrate vs. Benzoate in Urea Cycle Disorders

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Conditions

• Urea Cycle Disorders, Inborn

Interventions

Type	Name	Description
DRUG	Sodium Benzoate	Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.
DRUG	Sodium Phenylbutyrate	Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2014-04-11
• Last updated: 2018-01-09
• Results posted: 2017-12-08

Locations

1 site across 1 country: United States