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NCT00775528 · ClinicalTrials.gov registry record · Phase 3
Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
A Phase 3 study, sponsored by Solvay Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 19
- Enrollment target
NCT00775528: Completed Phase 3 study, sponsored by Solvay Pharmaceuticals.
NCT00775528 is a Phase 3 study that has completed, run by Solvay Pharmaceuticals. 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
NCT00775528, a Phase 3 study, has completed, sponsored by Solvay Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 19 participants
- Enrollment target
Study Summary
This study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis.
Primary Outcome
Treatment Emergent Adverse Events are defined as adverse events started at or after the first administration of study drug and include those events started prior to the first administration but which worsened after the first intake.
Interventions
- DRUG Pancrelipase Delayed Release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2009-04 |
| Est. Completion | 2009-06 |
| Phase | Phase 3 |
What the finished NCT00775528 record still lists
NCT00775528 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 Pancrelipase Delayed Release is the first listed.
NCT00775528 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00775528 about?
NCT00775528 is a clinical study titled "Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis". This study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis.
What is the current status of trial NCT00775528?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 19 participants. The study started on 2009-04. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00775528?
The interventions under investigation include: Pancrelipase Delayed Release (DRUG).
Who is sponsoring clinical trial NCT00775528?
This trial is sponsored by Solvay Pharmaceuticals, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00775528'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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