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NCT02279498 · ClinicalTrials.gov registry record · Phase 3
SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis
A Phase 3 study, sponsored by Anthera Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 128
- Enrollment target
NCT02279498 is a Phase 3 study that has completed, run by Anthera Pharmaceuticals. The registered enrollment target is 128 participants.
The verdict
NCT02279498, a Phase 3 study, has completed, sponsored by Anthera Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 128 participants
- Enrollment target
Study Summary
Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes including lipase, protease, and amylase. The purpose of the present study is to provide additional efficacy and safety data compared to approved, porcine-derived, enterically-coated and encapsulated pancreatic enzyme replacement therapy. The primary efficacy endpoint of the study will be comparative efficacy measured as the change in the coefficient of fat absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI). Liprotamase is stable in stomach and digestive fluids allowing administration in a variety of convenient formulations and with a number of foods without enteric coating.
Interventions
- DRUG Liprotamase
- DRUG porcine (pig) PERT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2015-06 |
| Est. Completion | 2017-01-20 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02279498
The ClinicalTrials.gov registry entry for NCT02279498 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Anthera Pharmaceuticals, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Liprotamase is the first listed.
NCT02279498 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02279498 about?
NCT02279498 is a clinical study titled "SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis". Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes including lipase, protease, and amylase. The purpose of the present study is to provide additional efficacy and safety data compared to approved, porcine-derived, enterically-coated and encapsulated pancreatic...
What is the current status of trial NCT02279498?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 128 participants. The study started on 2015-06. Estimated completion is 2017-01-20.
What interventions are being tested in trial NCT02279498?
The interventions under investigation include: Liprotamase (DRUG), porcine (pig) PERT (DRUG).
Who is sponsoring clinical trial NCT02279498?
This trial is sponsored by Anthera Pharmaceuticals, which has 16 total clinical trials registered on ClinicalTrials.gov.
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