NCT00742092

Miglustat in Cystic Fibrosis

Single Center, Double-blind, Randomized, Placebo-controlled, Two-period/Two-treatment Crossover Study Investigating the Effect of Miglustat on the Nasal Potential Difference in Patients With Cystic Fibrosis Homozygous for the F508del Mutation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Single Center, Double-Blind, Randomized, Placebo-Controlled, Two-Period/Two-Treatment Crossover Study Investigating the Effect of Miglustat on the Nasal Potential Difference in Patients With Cystic Fibrosis Homozygous for the F508del Mutation

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	miglustat	Oral miglustat capsules 200 mg t.i.d. (three times a day) for 7 days and a single 200 mg dose on Day 8
DRUG	placebo	Oral placebo capsules matching in appearance miglustat capsules given t.i.d. (three times a day) for 7 days and a single dose on Day 8

Timeline

• Start date: 2008-08-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-08-27
• Last updated: 2014-03-07

Locations

1 site across 1 country: Belgium