Who is sponsoring NCT00880100?

NCT00880100 is sponsored by Forest Laboratories.

What condition does NCT00880100 study?

NCT00880100 studies Cystic Fibrosis, Pancreatic Insufficiency.

What is the status of NCT00880100?

NCT00880100 is currently COMPLETED.

Last reviewed 2017-02-08 · How we verify

Efficacy and Safety of Ultrase MT12 in the Control of Steatorrhea in Cystic Fibrosis (CF) and Pancreatic Insufficient (PI) Children Aged 2 to 6 Years Old

NCT00880100 Phase 3 COMPLETED Results posted

Multicenter, explorative, phase IIIb, open-label study to assess the efficacy and safety of Ultrase® MT12, in the control of steatorrhea and clinical signs and symptoms of malabsorption in CF children with pancreatic insufficiency (PI). This study is sponsored by Aptalis Pharma (formerly Axcan).

Details

Lead sponsor	Forest Laboratories
Phase	Phase 3
Status	COMPLETED
Enrolment	49
Start date	2009-04
Completion	2009-11

Conditions

Cystic Fibrosis
Pancreatic Insufficiency

Interventions

Ultrase® MT12

Primary outcomes

Percentage of Patients With Control of Steatorrhea — A period of 19 to 24 days, from Baseline (Visit 2) to Day 15 to19 of Treatment Phase (Visit 3)
Control of steatorrhea was defined as a less than 30 percent (%) of fat in stools as measured by nuclear magnetic resonance (NMR) spectroscopy in all stool samples which are collected at baseline phase (usual pancreatic enzymes) during which the patients were on their prescribed pancreatic enzyme product (PEP) and during the 5-day collection period of the treatment phase during which the PEP was replaced with Ultrase MT12.

Countries

United States