A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 16, 2006

Last Updated Date

April 28, 2009

Start Date ^†

May 2007

Current Primary Outcome Measures ^†

Change in CFA from baseline to the end of double-blind treatment [ Time Frame: 7 days after baseline ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00400842 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Stool fat excretion, stool weight, stool frequency, nutritional parameters [ Time Frame: 7 days after baseline ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency

Official Title ^†

A Double-Blind, Placebo-Controlled, Parallel-Group, Comparative Study to Confirm the Safety and Efficacy of Oral 1.5 g/Day and 3.0 g/Day of SA-001 in Patients With Pancreatic Exocrine Insufficiency Caused by Chronic Pancreatitis or by Pancreatectomy

Brief Summary

This study is to verify the efficacy of 3.0 g/day of SA-001 in patients with pancreatic exocrine insufficiency caused by chronic pancreatitis in the non-compensatory stage or by pancreatectomy as compared with placebo under a double-blind design using the change in a coefficient of fat absorption as a primary endpoint.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Exocrine Pancreatic Insufficiency
Chronic Pancreatitis

Intervention ^†

Drug: SA-001
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

Estimated Completion Date

November 2009

Estimated Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Subjects with chronic pancreatitis in the non-compensatory stage or pancreatectomy
Subjects whose CFA is 80% or less
Subjects who are able to be hospitalized

Exclusion Criteria:

Subjects who are judged to be difficult to have at least 40 g/day of fat intake during course of the study
Subjects who have a known allergy to porcine protein and/or any component of digestive enzyme preparations
Subjects who are in the acute phase of chronic pancreatitis
Subjects with non-pancreatic malabsorption syndrome
Subjects with acute pancreatitis or ileus

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Toshiaki Yamaguchi

Toshiaki.Yamaguchi@solvay.com

Location Countries ^†

Japan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00400842

Responsible Party

Toshiaki Yamaguchi, Solvay Pharmaceuticals

Secondary IDs ^††

Study Sponsor ^†

Solvay Pharmaceuticals

Collaborators ^††

Investigators ^†

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

Information Provided By

Solvay Pharmaceuticals

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.