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NCT00981214 · ClinicalTrials.gov registry record · Phase 3
Study of Pancreatic Enzyme Product in Pediatric Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
A Phase 3 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 19
- Enrollment target
NCT00981214: Completed Phase 3 study, sponsored by Forest Laboratories.
NCT00981214 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 19 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00981214, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 19 participants
- Enrollment target
Study Summary
This is an open-label study to evaluate the efficacy and safety of Aptalis' (formerly Eurand) pancreatic enzyme product (PEP) microtabs in pediatric participants under age 7 with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI).
Primary Outcome
Responders were defined as those participants without steatorrhea (defined as less than 30 percent (%) fecal fat content) and without signs and symptoms of malabsorption after 1 week of treatment with study medication.
Interventions
- DRUG EUR-1008 (APT-1008)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2006-05 |
| Est. Completion | 2006-09 |
| Phase | Phase 3 |
What the finished NCT00981214 record still lists
NCT00981214 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which EUR-1008 (APT-1008) is the first listed.
NCT00981214 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00981214 about?
NCT00981214 is a clinical study titled "Study of Pancreatic Enzyme Product in Pediatric Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency". This is an open-label study to evaluate the efficacy and safety of Aptalis' (formerly Eurand) pancreatic enzyme product (PEP) microtabs in pediatric participants under age 7 with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI).
What is the current status of trial NCT00981214?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 19 participants. The study started on 2006-05. Estimated completion is 2006-09.
What interventions are being tested in trial NCT00981214?
The interventions under investigation include: EUR-1008 (APT-1008) (DRUG).
Who is sponsoring clinical trial NCT00981214?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00981214's enrollment target sits among peer trials
19 1969th of 2000 higher than 31 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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