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NCT00414908 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy
A Phase 3 study, sponsored by Solvay Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 52
- Enrollment target
NCT00414908: Completed Phase 3 study, sponsored by Solvay Pharmaceuticals.
NCT00414908 is a Phase 3 study that has completed, run by Solvay Pharmaceuticals. The registered enrollment target is 52 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00414908, a Phase 3 study, has completed, sponsored by Solvay Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 52 participants
- Enrollment target
Study Summary
This study assessed the effect of pancrelipase delayed release capsules on fat and nitrogen absorption in subjects with PEI due to Chronic Pancreatitis and Pancreatectomy. There was a run-in with a 5-day of single-blind placebo treatment, followed by a 7-day Double-blind period and a 6-month Open-Label Follow-up.
Primary Outcome
The CFA is calculated from fat intake and fat excretion : 100\*\[fat intake-fat excretion\]/fat intake. Higher values indicated a better response. Change is calculated as (DB CFA-Baseline CFA).
Interventions
- DRUG Placebo Comparator
- DRUG Pancrelipase delayed release capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-12 |
| Phase | Phase 3 |
What the finished NCT00414908 record still lists
NCT00414908 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Comparator is the first listed.
NCT00414908 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00414908 about?
NCT00414908 is a clinical study titled "A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy". This study assessed the effect of pancrelipase delayed release capsules on fat and nitrogen absorption in subjects with PEI due to Chronic Pancreatitis and Pancreatectomy. There was a run-in with a 5-day of single-blind placebo treatment, followed by a 7-day Double-blind period and a 6-month Open-La...
What is the current status of trial NCT00414908?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 52 participants. The study started on 2007-10. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00414908?
The interventions under investigation include: Placebo Comparator (DRUG), Pancrelipase delayed release capsule (DRUG).
Who is sponsoring clinical trial NCT00414908?
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 NCT00414908's enrollment target sits among peer trials
52 1841st of 2000 higher than 159 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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