Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Actelion |
---|---|
Information provided by: | Actelion |
ClinicalTrials.gov Identifier: | NCT00742092 |
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
Condition | Intervention | Phase |
---|---|---|
Cystic Fibrosis |
Drug: miglustat Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 15 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
miglustat
|
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
|
2: Placebo Comparator
placebo
|
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
|
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male or female Non-pregnant women who are to remain non-pregnant for 3 months after the end of the study. Women of childbearing potential must use a reliable method of contraception. Reliable methods of contraception for female patients include the following:
Age > 55 years and treated with HRT prior to screening with an appropriate medical documentation of spontaneous amenorrhea for at least 24 months. For female patients in the pediatric age range, a reliable method of contraception must be considered, if appropriate.
Exclusion Criteria:
Belgium | |
Universite Catholique de Louvain | Recruiting |
Brussels, Belgium, B-1200 | |
Contact: Patrick Lebecque, MD, PhD 32 2 764 1111 patrick_lebecque@hotmail.com | |
Contact: Teresinha Leal, PhD 32 2 764 6724 teresina.leal@uclouvain.be | |
Principal Investigator: Patrick Lebecque, MD, PhD | |
Sub-Investigator: Teresinha Leal, PhD |
Principal Investigator: | Patrick Lebecque, MD, PhD | Catholic University of Louvain |
Responsible Party: | Actelion ( Actelion Pharmaceuticals, Ltd. / Sponsor ) |
Study ID Numbers: | AC-056A202 |
Study First Received: | August 26, 2008 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00742092 |
Health Authority: | Belgium: Institutional Review Board; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Belgium: Directorate general for the protection of Public health: Medicines |
Miglustat Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis |
Fibrosis Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases Cystic fibrosis |
Anti-Infective Agents Anti-HIV Agents Pathologic Processes Anti-Retroviral Agents Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Enzyme Inhibitors Antiviral Agents Pharmacologic Actions |