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Nutritional-GI Completed with Results
Study of in-line digestive enzyme cartridge (Relizorb) in people with CF who are currently receiving enteral tube feedings (Alcresta 0000497)
This study looked at the safety and effectiveness of Relizorb®, a new digestive enzyme cartridge designed for people with pancreatic insufficiency (PI) that can be used in-line with enteral tube feeding. This cartridge delivers the digestive enzyme lipase, which helps the body digest fats contained in the tube-feeding formula. The study was divided into three parts. Part 1 was a 7-day observational period where participants used a standardized higher-fat enteral formula in place of their usual formula. Part 2 compared active treatment where participants used the Relizorb® cartridge or a placebo cartridge. Part 3 was a 7-day open-label safety period where all participants used the Relizorb® cartridge. Participants were instructed to maintain their usual treatment regimen, including their usual dose of pancreatic enzyme replacement therapy (PERT) products, during Parts 1 and 3.
Eligibility
See other primary eligibility criteria for more information.
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Age:
4 Years to 82 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
Less than 100%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Patients must be current enteral formula user at least 4-5 times/week, using PERTs, consuming an unrestricted fat diet, receptive to diet recall telephone calls and willing to use Peptamen AF
Study Results
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What We Learned:
This study found that participants with pancreatic insufficiency (PI) who use Relizorb®, a new enteral tube feeding in-line digestive enzyme cartridge, were better able to absorb fat during their enteral tube feedings. Relizorb® was safe and well-tolerated.
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Primary Findings:
Effectiveness:
This study was conducted between December 2015 and May 2016. Of the 34 participants enrolled, 33 were randomized and completed the study. One participant withdrew after hospitalization for a pulmonary exacerbation unrelated to the study. The primary endpoints were safety, tolerability and to test the device’s effectiveness as measured by fat absorption (change in fatty acid concentrations) over a 24-hour period. Compared with the placebo cartridge, the Relizorb® cartridge resulted in a significantly higher amount of fat absorbed (increased by a factor of 2.8 (537.0 vs. 192.2 ugxh/mL), p < 0.001).
Safety:
The Relizorb® cartridge was generally safe and well-tolerated.
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Citation:
J Pediatr Gastroenterol Nutr ;DOI 10.1097/MPG.0000000000001617 [Epub ahead of print]
For current information about the overall development status of this drug, please check the Drug Development Pipeline.
Study Design
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Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
No -
Length of Participation:
27 days -
Number of Study Visits:
4
Additional Information
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Phase: ?more info
Not Applicable -
Study Sponsor: ?more info
Alcresta -
Study Drugs:
N/A
Eligibility
See other primary eligibility criteria for more information.
-
Age:
4 Years to 82 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
Less than 100%
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Patients must be current enteral formula user at least 4-5 times/week, using PERTs, consuming an unrestricted fat diet, receptive to diet recall telephone calls and willing to use Peptamen AF
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