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NCT00297167 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
A Phase 3 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 34
- Enrollment target
NCT00297167 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 34 participants.
The verdict
NCT00297167, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 34 participants
- Enrollment target
Study Summary
The primary efficacy objective of this study is to compare the coefficient of fat absorption (CFA) following oral administration of Aptalis Pharma's (formerly Eurand Pharmaceuticals) pancreatic enzyme product (PEP) capsules and placebo in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI).
Interventions
- DRUG Placebo
- DRUG EUR-1008 (APT-1008)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2006-05 |
| Est. Completion | 2006-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00297167
The ClinicalTrials.gov registry entry for NCT00297167 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00297167 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00297167 about?
NCT00297167 is a clinical study titled "Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency". The primary efficacy objective of this study is to compare the coefficient of fat absorption (CFA) following oral administration of Aptalis Pharma's (formerly Eurand Pharmaceuticals) pancreatic enzyme product (PEP) capsules and placebo in participants with cystic fibrosis (CF) and exocrine pancreati...
What is the current status of trial NCT00297167?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 34 participants. The study started on 2006-05. Estimated completion is 2006-11.
What interventions are being tested in trial NCT00297167?
The interventions under investigation include: Placebo (DRUG), EUR-1008 (APT-1008) (DRUG).
Who is sponsoring clinical trial NCT00297167?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
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