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NCT02734810 · ClinicalTrials.gov registry record · Phase 3
SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis
A Phase 3 study of Cystic Fibrosis and Exocrine Pancreatic Insufficiency, sponsored by Anthera Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 15
- Enrollment target
- 20
- Study locations
NCT02734810: Completed Phase 3 study of Cystic Fibrosis and Exocrine Pancreatic Insufficiency, sponsored by Anthera Pharmaceuticals.
NCT02734810 is a Phase 3 study of Cystic Fibrosis and Exocrine Pancreatic Insufficiency that has completed, run by Anthera Pharmaceuticals. The registered enrollment target is 15 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02734810, a Phase 3 study of Cystic Fibrosis and Exocrine Pancreatic Insufficiency, has completed, sponsored by Anthera Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 15 participants
- Enrollment target
- 20
- Study locations
Study Summary
Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration either as a capsule or as a dosing solution dissolved in water or juice. The purpose of the present study is to provide efficacy and safety data for a new, soluble formulation of liprotamase, Liprotamase Powder for Oral Solution, in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).
Primary Outcome
Number of subjects reporting 1 or more adverse events
Conditions Studied
Interventions
- DRUG Liprotamase Powder for Oral Solution
Study Locations (20)
Florida
- Investigator Site 117 - Altamonte Springs
- Investigator Site 138 - Hollywood
- Investigator Site 130 - Miami
Oklahoma
- Investigator Site 101 - Oklahoma City
- Investigator Site 136 - Oklahoma City
Texas
- Investigator Site 111 - Dallas
- Investigator Site 116 - Houston
Arkansas
- Investigator Site 139 - Little Rock
California
- Investigator Site - Orange
Colorado
- Investigator Site 114 - Aurora
Georgia
- Investigator Site 110 - Atlanta
Illinois
- Investigator Site 109 - Glenview
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2016-06 |
| Est. Completion | 2017-03 |
| Phase | Phase 3 |
What the finished NCT02734810 record still lists
NCT02734810 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which Liprotamase Powder for Oral Solution is the first listed.
NCT02734810 names 20 study sites across 16 states, led by Florida, Oklahoma, Texas.
Frequently Asked Questions
What is clinical trial NCT02734810 about?
NCT02734810 is a clinical study titled "SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis". Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration either as a capsule or as a dosing solution dissolved in water or juice. T...
What is the current status of trial NCT02734810?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 15 participants. The study started on 2016-06. Estimated completion is 2017-03.
What conditions does trial NCT02734810 study?
This clinical trial studies the following conditions: Cystic Fibrosis, Exocrine Pancreatic Insufficiency.
What interventions are being tested in trial NCT02734810?
The interventions under investigation include: Liprotamase Powder for Oral Solution (DRUG).
Who is sponsoring clinical trial NCT02734810?
This trial is sponsored by Anthera Pharmaceuticals, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02734810 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02734810's enrollment target sits among peer trials
15 145th of 169 higher than 22 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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