82
Participants
Start Date
January 31, 2008
Primary Completion Date
March 31, 2009
Study Completion Date
March 31, 2009
Placebo
Placebo matching to EUR-1008 (APT-1008) capsules orally daily for 4 days home treatment and 3 to 5 days hospital treatment in the baseline run-in phase, which will then be randomized to either high dose or low dose of EUR-1008 (APT-1008).
EUR-1008 (APT-1008) High Dose
EUR-1008 (APT-1008) total high dose 140,000 lipase USP Lipase units will be given as 7 capsules containing 20,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
EUR-1008 (APT-1008) Low Dose
EUR-1008 (APT-1008) total low dose 35,000 lipase USP Lipase units will be given as 7 capsules containing 5,000 USP Lipase units each, orally daily, distributed over the day per gram of fat in diet (possible example: 2 capsules with breakfast, 2 capsules with lunch, 2 capsules with dinner and 1 capsule with a snack) for 6 days home treatment and 3 to 5 days hospital treatment in either first intervention period or second intervention period.
Istituto Clinico Humanitas - Universita' Di Milano Via Manzoni, Rozzano
Advanced Medical Research Center, Port Orange
University of Florida, General Clinical Research Center, Gainesville
University of Louisville, Carmichael Building, Louisville
University of Kentucky, Medical Center, Department of Gastroenterology, Lexington
University of Iowa Hospitals and Clinics, Iowa Ctiy
Veterans Affairs Edward Jr. Hines Hospital, Building #1, Hines
Department of Liver and Gastrointestinal Tract Disease Institute of Therapy named after L.T. Maylaya of Academy of Medical Sciences of the Ukraine, Kharkiv
University of Missouri Health Care, Columbia
Woodland International Research Group, Little Rock
Department of Internal Medicine No 2 of Donetsk State University named after M. Gorkly, City Clinical Hospital No 3, Donetsk
HealthCare Partners Medical Group, Los Angeles
Department of Therapy and Family Medicine of the Facility of Post graduate Education of Crimea State Medical University named after S.I. Georglyevskyy Republic Clinical Hospital named after M.O. Semashko, Simferopol
Dipartmento di Malattie dell' apparato digerente e Medicina Interna- Unita Operativa di MedicinaInterna Corinaldesi Azienda Ospedaliero- Universitaria Policlinico Sant'Orsola Malpighi Via Massarenti, Massarenti
Istituto di Clinica Chirurgica (Ensoscopia Digestive Chirurgica) Policlinico Gemelli-Universita Cattolica del Sacro Cuore, Largo Agostino Gemelli
Centro Richerche Cliniche di Verona, Le Ludovico Scuro
Department of Faculty Therapy No 1 with the Course of Postgraduate Training of Physicians for Gastroenterology and Endoscopy, National Medical University named after O.O. Bogomolets, City Hospital No 18, Kyiv
General Therapy Clinic, Military Clinical Hospital of Ministry of Defense of Ukraine 18, Kyiv
Lead Sponsor
Forest Laboratories
INDUSTRY