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)

Summary

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).

Timeline

Start

2008-01

Primary completion

2009-03

Completion

2009-03

Outcome

Missed primary endpoint

registry p = 0.228; Least Square (LS) Mean Difference 1.023 (95% CI -0.656 to 2.701); ANCOVA NCT00788593 ↗

Drugs

Indications