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| Sponsor: | Altus Pharmaceuticals |
|---|---|
| Collaborator: |
Cystic Fibrosis Foundation |
| Information provided by: | Altus Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00095732 |
Purpose
The purpose of this study is to determine the most effective dose of a new enzyme therapy on oral nutrient absorption in cystic fibrosis (CF) subjects with exocrine pancreatic insufficiency.
| Condition | Intervention | Phase |
|---|---|---|
|
Cystic Fibrosis Pancreatic Insufficiency |
Drug: TheraCLEC™ – Total |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study |
| Official Title: | A Phase 2, Randomized, Double Blind, Parallel Dose Ranging Study of Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency |
| Estimated Enrollment: | 126 |
| Study Start Date: | June 2004 |
| Estimated Study Completion Date: | March 2005 |
Eligibility| Ages Eligible for Study: | 7 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 27 Study Locations
More Information
| Study ID Numbers: | TC-2A |
| Study First Received: | November 9, 2004 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00095732 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Enzymes Pancreatic Insufficiency Cystic Fibrosis |
|
Pathologic Processes Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis |
Fibrosis Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases Exocrine Pancreatic Insufficiency |