A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency

Abbott

Status and phase: Completed; Phase 3

Conditions: Exocrine Pancreatic Insufficiency, Chronic Pancreatitis

Treatments: Drug: Placebo; Drug: SA-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT00400842

S245.3.122

Details and patient eligibility

About

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.

Enrollment: 274 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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274 participants in 3 patient groups, including a placebo group

L

Experimental group

Treatment:

Drug: SA-001

Drug: SA-001

H

Experimental group

Treatment:

Drug: SA-001

Drug: SA-001

P

Placebo Comparator group

Treatment:

Drug: Placebo