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NCT01100606 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of Age
A Phase 4 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT01100606 is a Phase 4 study that has completed, run by Forest Laboratories. The registered enrollment target is 15 participants.
The verdict
NCT01100606, a Phase 4 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study Summary
A study to determine the safety, effectiveness, and acceptability of 2 methods of administration of EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) 3,000 lipase units capsule, a pancreatic enzyme product (PEP), in infants with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). This study is sponsored by Aptalis Pharma (formerly Eurand).
Interventions
- DRUG EUR-1008 (APT-1008)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2010-06 |
| Est. Completion | 2010-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01100606
The ClinicalTrials.gov registry entry for NCT01100606 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 15 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 1 intervention - of which EUR-1008 (APT-1008) is the first listed.
NCT01100606 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01100606 about?
NCT01100606 is a clinical study titled "A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of Age". A study to determine the safety, effectiveness, and acceptability of 2 methods of administration of EUR-1008 (APT-1008) (Zenpep® \[pancrelipase\] delayed release capsule) 3,000 lipase units capsule, a pancreatic enzyme product (PEP), in infants with exocrine pancreatic insufficiency (EPI) due to cys...
What is the current status of trial NCT01100606?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2010-06. Estimated completion is 2010-12.
What interventions are being tested in trial NCT01100606?
The interventions under investigation include: EUR-1008 (APT-1008) (DRUG).
Who is sponsoring clinical trial NCT01100606?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
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