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Completed Phase 3 Interventional Results available

Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

ClinicalTrials.gov ID: NCT00775528

Public ClinicalTrials.gov record NCT00775528. 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.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 12:14 PM EDT

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, Multi-center, Study to Assess the Safety and Tolerability of Pancrelipase Delayed Release Capsules in Infants and Children Less Than 7 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis.

Study identification

NCT ID
NCT00775528
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Solvay Pharmaceuticals
Industry
Enrollment
19 participants

Conditions and interventions

Eligibility (public fields only)

Age range
1 Month to 6 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 2009 (Type not available)
Primary completion
Jun 2009 (Actual)
Completion
Jun 2009 (Actual)
Last update posted
Nov 8, 2010

2009

United States locations

U.S. sites
12
U.S. states
10
U.S. cities
11
Facility City State ZIP Site status
Site 11 Boise Idaho — —
Site 5 Louisville Kentucky — —
Site 9 Boston Massachusetts — —
Site 6 Ann Arbor Michigan — —
Site 12 Detroit Michigan — —
Site 4 Minneapolis Minnesota — —
Site 13 Long Branch New Jersey — —
Site 8 Albuquerque New Mexico — —
Site 1 Cincinnati Ohio — —
Site 10 Oklahoma City Oklahoma — —
Site 7 Oklahoma City Oklahoma — —
Site 3 Hershey Pennsylvania — —

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 NCT00775528, 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 Nov 8, 2010 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00775528 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →