Who is sponsoring NCT00408317?

NCT00408317 is sponsored by Forest Laboratories.

What condition does NCT00408317 study?

NCT00408317 studies Cystic Fibrosis, Exocrine Pancreatic Insufficiency.

What drugs are being tested in NCT00408317?

Interventions: Ultrase® MT20, Placebo.

What is the status of NCT00408317?

NCT00408317 is currently COMPLETED.

Last reviewed 2017-02-07 · How we verify

A Multicenter, Randomized, Double-Blind, Crossover Study to Compare the Safety and Efficacy of Ultrase® MT20 to Placebo for the Correction of Steatorrhea in Patients With Cystic Fibrosis (CF)

NCT00408317 Phase 3 COMPLETED Results posted

The purpose of this study is to assess the safety and efficacy of Ultrase® MT20 compared to placebo for the correction of fat and protein malabsorption in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI). This study is sponsored by Aptalis Pharma (formerly Axcan).

Details

Lead sponsor	Forest Laboratories
Phase	Phase 3
Status	COMPLETED
Enrolment	36
Start date	2006-11
Completion	2007-04

Conditions

Cystic Fibrosis
Exocrine Pancreatic Insufficiency

Interventions

Ultrase® MT20
Placebo

Primary outcomes

Percent Coefficient of Fat Absorption (CFA) — Day 3 to Day 7 in first intervention period and second intervention period
Percent (%) CFA was calculated as (\[fat intake - fat excretion\]/fat intake)\*100, determined by the stools collected during the 72-hour period which could extend to 96 hours during both intervention periods. Mean CFA percent was calculated for 72-hour/96-hour period during Day 3 to Day 7 in the first and second intervention periods.

Countries

United States