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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02734810
The ClinicalTrials.gov registry entry for NCT02734810 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (92% lower). The listed sponsor is Anthera Pharmaceuticals, which has 16 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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.
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