NCT00559364 - Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

July 31, 2009

Study Completion Date

July 31, 2009

Conditions

Exocrine Pancreatic InsufficiencyChronic PancreatitisPancreatectomy

Interventions

DRUG

Viokase® 16

Patients assigned to Viokase® 16 will be given 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase.

DRUG

Placebo

Patients assigned to placebo will be given 22 matching placebo tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase.

DRUG

Proton pump inhibitor (PPI)

Patients on PPI during Screening will continue their usual PPI therapy throughout the study.

DRUG

Omeprazole

Patients not using PPI therapy at Screening will be given omeprazole 20 milligram orally once daily throughout the study.

Trial Locations (18)

03756

Darmouth-Hitchcock Medical Center, Lebanon

G6V 3Z1

Hotel-Dieu de Levis, Lévis

15 950

III Oddzial Chorób Wewnetrznych i Gastroenterologii, Bialystok

80 952

Akademickie Centrum Kliniczne, Gdansk

40 752

Samodzielny Publiczny Centralny, Katowice

30 901

Klinika Chorob Wewnetrznych z Poliklinika, Krakow

90 153

Uniwersytecki Szpital Kliniczny nr 1 im, Lodz

20 954

SP Szpital Kliniczny nr 4 w Lublinie, Lublin

40 200

Wojewodzki Szpital Specjalistyczny Nr5, Sosnowiec

71 252

SP Szpital Kliniczny nr 1 Klinika Gastroenterologii, Szczecin

02 097

Klinika Gastroenterologii i Chorób Przemiany Materii, Warsaw

02 507

Klinika Chorob Wewnetrznych i Gastroenterologii, Warsaw

03 242

Wojewodzki Szpital Brodnowski, Warsaw

50 376

Katedra Klinika Gastroenterologii, Wroclaw

851 07

University Hospital Brastislava, Brastislava

826 06

University Hospital Bratislava, Bratilslava

949 01

NZZ Management spol.S.r.o., Nitra

080 01

Gastro I. s.r.o., Gastroenterologicka, Prešov