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NCT00510484 · ClinicalTrials.gov registry record · Phase 3
Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
A Phase 3 study, sponsored by Solvay Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 35
- Enrollment target
NCT00510484: Completed Phase 3 study, sponsored by Solvay Pharmaceuticals.
NCT00510484 is a Phase 3 study that has completed, run by Solvay Pharmaceuticals. The registered enrollment target is 35 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00510484, a Phase 3 study, has completed, sponsored by Solvay Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 35 participants
- Enrollment target
Study Summary
This study will assess the effect of pancrelipase delayed release 24,000 unit capsules on fat and nitrogen absorption in subjects with PEI due to Cystic Fibrosis.
Primary Outcome
This coefficient is calculated from fat intake and fat excretion : 100\*\[fat intake-fat excretion\]/fat intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.
Interventions
- DRUG Placebo Comparator
- DRUG Pancrelipase Delayed Release
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2007-11 |
| Est. Completion | 2008-03 |
| Phase | Phase 3 |
What the finished NCT00510484 record still lists
NCT00510484 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Comparator is the first listed.
NCT00510484 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00510484 about?
NCT00510484 is a clinical study titled "Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis". This study will assess the effect of pancrelipase delayed release 24,000 unit capsules on fat and nitrogen absorption in subjects with PEI due to Cystic Fibrosis.
What is the current status of trial NCT00510484?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 35 participants. The study started on 2007-11. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00510484?
The interventions under investigation include: Placebo Comparator (DRUG), Pancrelipase Delayed Release (DRUG).
Who is sponsoring clinical trial NCT00510484?
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 NCT00510484's enrollment target sits among peer trials
35 1903rd of 2000 higher than 96 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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