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)

ClinicalTrials.gov ID: NCT00788593

Public ClinicalTrials.gov record NCT00788593. 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.

View official ClinicalTrials.gov record → Back to search

ClinicalTrials.gov public records Last synced Sep 2, 2026, 8:04 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 in Chronic Pancreatitis (CP) Patients With Exocrine Pancreatic Insufficiency (EPI)

Brief summary

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

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).

Study identification

NCT ID: NCT00788593
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Forest Laboratories; Industry
Enrollment: 82 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
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: Dec 31, 2007
Primary completion: Feb 28, 2009
Completion: Feb 28, 2009
Last update posted: Mar 11, 2014

2008 – 2009

United States locations

U.S. sites: 9
U.S. states: 7
U.S. cities: 9

Facility	City	State	ZIP	Site status
Woodland International Research Group	Little Rock	Arkansas	72211	—
HealthCare Partners Medical Group	Los Angeles	California	90015	—
University of Florida, General Clinical Research Center	Gainesville	Florida	32610	—
Advanced Medical Research Center	Port Orange	Florida	32127	—
Veterans Affairs Edward Jr. Hines Hospital, Building #1	Hines	Illinois	60141	—
University of Iowa Hospitals and Clinics	Iowa Ctiy	Iowa	52242	—
University of Kentucky, Medical Center, Department of Gastroenterology	Lexington	Kentucky	40536	—
University of Louisville, Carmichael Building	Louisville	Kentucky	40202	—
University of Missouri Health Care	Columbia	Missouri	65212	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00788593, 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 11, 2014 · Synced Sep 2, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00788593 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →