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A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency

NCT00400842 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2011-07-28

No results posted yet for this study

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.

Conditions

  • Exocrine Pancreatic Insufficiency, Chronic Pancreatitis

Interventions

DRUG

SA-001

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

DRUG

SA-001

0.25 g of SA-001 pellets/capsule, 6 capsules/day for 7 days

DRUG

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • Toshiaki Yamaguchi, BS Pharm · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00400842 on ClinicalTrials.gov