Study of Pancreatic Enzyme Product in Pediatric Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
Public ClinicalTrials.gov record NCT00981214. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label Study to Evaluate the Efficacy and Safety of Pancreatic Enzyme Product (PEP) Microtabs in Pediatric Patients With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an open-label study to evaluate the efficacy and safety of Aptalis' (formerly Eurand) pancreatic enzyme product (PEP) microtabs in pediatric participants under age 7 with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI).
Study identification
- NCT ID
- NCT00981214
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 19 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 7 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2006
- Primary completion
- Aug 31, 2006
- Completion
- Aug 31, 2006
- Last update posted
- Mar 15, 2017
2006
United States locations
- U.S. sites
- 14
- U.S. states
- 10
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | — |
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | — |
| Children's Hospital - Oakland | Oakland | California | 94609 | — |
| Stanford University Medical Center | Palo Alto | California | 94304 | — |
| Children's Hospital of San Diego | San Diego | California | 92123 | — |
| University of Florida College of Medicine | Gainsville | Florida | 32610-0296 | — |
| Nemours Childrens Clinic | Jacksonville | Florida | 32250 | — |
| Childrens Memorial Hospital | Chicago | Illinois | 60614 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| University of Michigan, Cystic Fibrosis Center | Ann Arbor | Michigan | 48109 | — |
| Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| University of Texas | Tyler | Texas | 75708 | — |
| University of Utah | Salt Lake City | Utah | 84108 | — |
| West Virginia Health Sciences Center | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00981214, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 15, 2017 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00981214 live on ClinicalTrials.gov.