NCT02598128

Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb)

Study to Evaluate Safety, Tolerability and Fat Absorption Using a Novel Enteral Feeding In-line Digestive Enzyme Cartridge (RELIZORB) in Patients With Cystic Fibrosis Receiving Enteral Feeding

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Alcresta Therapeutics, Inc. · Industry
• Sex: All
• Age: 4 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Exocrine Pancreatic Insufficiency

Interventions

Type	Name	Description
DEVICE	RELiZORB	Peptamen 1.5 received Period A and Period B (washout only). Impact Peptide 1.5 received Period B (Days 1 and 9 only) and Period C.
DEVICE	Placebo	Sham device

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-11-05
• Last updated: 2017-01-25
• Results posted: 2017-01-20

Locations

11 sites across 1 country: United States