At a glance
ClinicalIndex Comparison RecordN/ACompleted· 34 enrolled
Drug / intervention
RELiZORB +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating RELiZORB and Placebo for Exocrine Pancreatic Insufficiency. Completed, enrolled 34 participants across 11 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsExocrine Pancreatic Insufficiency
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartNov 2015
First PostedNov 2015
Primary CompletionJun 2016
TodayJul 2026
First PostedNov 5, 2015
Enrollment StartNov 1, 2015
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.7 years ago
Interventions
RELiZORBdevice
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.
Placebodevice
Sham device