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Clinical Trial Summary

Protocol ALCT-0000497 is a multicenter safety, tolerability and fat absorption study that anticipates enrolling 35 male and female subjects (pediatric and adult) with cystic fibrosis. Subjects with confirmed exocrine pancreatic insufficiency will use a novel enteral feeding in-line digestive enzyme cartridge (RELiZORB) connected to enteral pump sets.


Clinical Trial Description

Protocol ALCT-0000497 consists of three distinct study periods as follows:

1. In Period A (7 days), subjects will receive Peptamen 1.5 enteral feedings at home.

2. In Period B (11 days), subjects will be randomized to either Group A (active investigational then placebo control) or Group B (placebo control then active investigational) and receive Impact Peptide 1.5 on Days 1 and 9. During the 8-day washout period between Days 1 and 9, subjects will receive Peptamen 1.5.

3. In Period C (9 days), subjects will use RELiZORB during nocturnal enteral feedings with Impact Peptide 1.5. ;


Study Design


Related Conditions & MeSH terms

  • Exocrine Pancreatic Insufficiency

NCT number NCT02598128
Study type Interventional
Source Alcresta Therapeutics, Inc.
Contact
Status Completed
Phase N/A
Start date November 2015
Completion date June 2016

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