A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00400842

Enrollment

274

Registered

2006-11-17

Start date

2007-05-31

Completion date

2009-08-31

Last updated

2011-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exocrine Pancreatic Insufficiency, Chronic Pancreatitis

Keywords

SA-001, Pancreatic Exocrine Insufficiency, 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.

Interventions

DRUGSA-001

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

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in CFA from baseline to the end of double-blind treatment	7 days after baseline

Secondary

Measure	Time frame
Stool fat excretion, stool weight, stool frequency, nutritional parameters	7 days after baseline

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026