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NCT01131507 · ClinicalTrials.gov registry record · Phase 4
PR-018: An Open-Label, Safety Extension of Study PR-011
A Phase 4 study of Cystic Fibrosis and Exocrine Pancreatic Insufficiency, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
- 6
- Study locations
NCT01131507: Completed Phase 4 study of Cystic Fibrosis and Exocrine Pancreatic Insufficiency, sponsored by Forest Laboratories.
NCT01131507 is a Phase 4 study of Cystic Fibrosis and Exocrine Pancreatic Insufficiency that has completed, run by Forest Laboratories. 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 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01131507, a Phase 4 study of Cystic Fibrosis and Exocrine Pancreatic Insufficiency, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
- 6
- Study locations
Study Summary
A study to evaluate long term safety and effect on ability to thrive of EUR-1008 (APT-1008) 3,000 lipase units (Zenpep® \[pancrelipase\] delayed release capsules) in infants with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).
Primary Outcome
TEAE was any event not present prior to exposure to study drug or any event already present that worsened in either intensity or frequency following exposure to test drug. Serious AE (SAE) was any event that resulted in death, immediately life threatening, hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Number of participants with TEAEs, SAEs, TEAE's relationship to study drug (unrelat
Conditions Studied
Interventions
- DRUG EUR-1008 (APT-1008)
Study Locations (6)
Ohio
- Akron Children's Hospital - Akron
- Cincinnati Children's Hospital Medical Center - Cincinnati
Florida
- Nemours Children's Clinic - Jacksonville
Nevada
- Children's Lung Specialists Ltd. - Las Vegas
Pennsylvania
- Penn State Milton S. Hershey Medical Center - Hershey
Texas
- Cystic Fibrosis Care Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-12 |
| Phase | Phase 4 |
What the finished NCT01131507 record still lists
NCT01131507 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 EUR-1008 (APT-1008) is the first listed.
NCT01131507 lists 6 locations in 5 states (Ohio, Florida, Nevada).
Frequently Asked Questions
What is clinical trial NCT01131507 about?
NCT01131507 is a clinical study titled "PR-018: An Open-Label, Safety Extension of Study PR-011". A study to evaluate long term safety and effect on ability to thrive of EUR-1008 (APT-1008) 3,000 lipase units (Zenpep® \[pancrelipase\] delayed release capsules) in infants with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).
What is the current status of trial NCT01131507?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2010-07. Estimated completion is 2011-12.
What conditions does trial NCT01131507 study?
This clinical trial studies the following conditions: Cystic Fibrosis, Exocrine Pancreatic Insufficiency.
What interventions are being tested in trial NCT01131507?
The interventions under investigation include: EUR-1008 (APT-1008) (DRUG).
Who is sponsoring clinical trial NCT01131507?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01131507 being conducted?
This trial has 6 study locations across Florida, Nevada, Ohio, Pennsylvania, Texas. 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 NCT01131507'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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