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Completed

NCT Number: NCT00400842

A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency

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.

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Key information

Conditions

Exocrine Pancreatic Insufficiency, Chronic Pancreatitis Chronic Disease Digestive System Diseases Disease Attributes Exocrine Pancreatic Insufficiency Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site Reference ID/Investigator# 59845, Aichi, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SA-001

Drug

0.25 g of SA-001 pellets/capsule, 12 capsules/day for 7 days

Placebo

Drug

Placebo

Primary outcomes

  1. Change in CFA from baseline to the end of double-blind treatment

    Time frame: 7 days after baseline

Secondary outcomes

  1. Stool fat excretion, stool weight, stool frequency, nutritional parameters

    Time frame: 7 days after baseline

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 17, 2006
Registry last updated
Jul 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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