A Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Pancreatic Exocrine Insufficiency - Tabular View

Tracking Information

First Received Date ^ICMJE

November 16, 2006

Last Updated Date

November 24, 2009

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Adverse events, vital signs, safety laboratory parameters [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Adverse events

Change History

Complete list of historical versions of study NCT00401076 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Nutritional parameters [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Change in Coefficient of Fat Absorption, Nutrition evaluation items

Descriptive Information

Brief Title ^ICMJE

A Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Pancreatic Exocrine Insufficiency

Official Title ^ICMJE

A One-year Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Patients With Pancreatic Exocrine Insufficiency Caused by Chronic Pancreatitis or by Pancreatectomy

Brief Summary

This study is to evaluate the safety of 3.0 g/day of SA-001 (to be flexibly increased or decreased with the range from 1.5 g/day to 6.0 g/day), which will orally be administered for 52 weeks to patients with pancreatic exocrine insufficiency caused by chronic pancreatitis in the non-compensatory stage or by Pancreatectomy.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Pancreatic Exocrine Insufficiency
Chronic Pancreatitis
Pancreatectomy

Intervention ^ICMJE

Drug: SA-001

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 ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2010

Estimated Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subjects who complete the S2453122 clinical study (excluding discontinued subjects)

Exclusion Criteria:

Subjects who are assessed to be inappropriate for continuing long-term use of SA-001, at the discretion of the investigator or the subinvestigator, because they experienced adverse drug reactions in the S2453122 clinical study

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00401076

Responsible Party

Toshiaki Yamaguchi, Solvay Pharmaceuticals

Study ID Numbers ^ICMJE

S245.3.123

Study Sponsor ^ICMJE

Solvay Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

Information Provided By

Solvay Pharmaceuticals

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP