NCT00880100

Use of Ultrase® MT12 in Young Cystic Fibrosis Children (CF)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This is a multicenter, explorative, phase IIIb, open-label study in patients with CF and PI. The study consists of a screening visit (visit 1), followed by a baseline phase of 9 days (plus a 5-day window if necessary) during which the regular pancreatic enzyme will be maintained and 10 stool samples will be collected over 5 days, for baseline evaluation of steatorrhea. Afterward, a treatment phase of 19 days (plus a 5-day window if necessary) with Ultrase® MT12 will follow (the usual pancreatic enzyme will be replaced by Ultrase® MT12). Over the last 5 days of the treatment phase, 10 additional stool samples will be collected, for evaluation of steatorrhea.

Conditions

• Cystic Fibrosis
• Pancreatic Insufficiency

Interventions

Type	Name	Description
DRUG	Ultrase® MT12	Ultrase® MT12 capsules will be given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose not to exceed 10,000 lipase units/kg/day.

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2009-04-13
• Last updated: 2017-03-16
• Results posted: 2015-02-19

Locations

15 sites across 1 country: United States