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NCT00788593 · ClinicalTrials.gov registry record · Phase 3
A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 (APT-1008) in Chronic Pancreatitis (CP) Participants With Exocrine Pancreatic Insufficiency (EPI)
A Phase 3 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 82
- Enrollment target
NCT00788593: Completed Phase 3 study, sponsored by Forest Laboratories.
NCT00788593 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 82 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00788593, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 82 participants
- Enrollment target
Study Summary
The primary efficacy objective of this study is to evaluate the difference in coefficient of fat absorption (CFA) of participants treated with high dose EUR-1008 (APT-1008) versus low dose of EUR-1008 (APT-1008) in the treatment of signs and symptoms of malabsorption in participants with EPI associated with CP. This study is sponsored by Aptalis Pharma (formerly Eurand).
Primary Outcome
Percent CFA was calculated as (\[fat intake - fat excretion\]/fat intake)\*100, determined in the stools collected during the 72-hour CFA determination period. Mean percent CFA was calculated for the 3 to 5 days of hospital treatment in first and second intervention periods.
Interventions
- DRUG Placebo
- DRUG EUR-1008 (APT-1008) High Dose
- DRUG EUR-1008 (APT-1008) Low Dose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2008-01 |
| Est. Completion | 2009-03 |
| Phase | Phase 3 |
What the finished NCT00788593 record still lists
NCT00788593 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00788593 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00788593 about?
NCT00788593 is a clinical study titled "A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 (APT-1008) in Chronic Pancreatitis (CP) Participants With Exocrine Pancreatic Insufficiency (EPI)". The primary efficacy objective of this study is to evaluate the difference in coefficient of fat absorption (CFA) of participants treated with high dose EUR-1008 (APT-1008) versus low dose of EUR-1008 (APT-1008) in the treatment of signs and symptoms of malabsorption in participants with EPI associa...
What is the current status of trial NCT00788593?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 82 participants. The study started on 2008-01. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00788593?
The interventions under investigation include: Placebo (DRUG), EUR-1008 (APT-1008) High Dose (DRUG), EUR-1008 (APT-1008) Low Dose (DRUG).
Who is sponsoring clinical trial NCT00788593?
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 NCT00788593's enrollment target sits among peer trials
82 1752nd of 2000 higher than 249 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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