NCT00400842CompletedPhase 3
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Abbott
- Enrollment
- 274
- Locations
- 98
- Primary Endpoint
- Change in CFA from baseline to the end of double-blind treatment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
P
Placebo Comparator
Intervention: Placebo (Drug)
L
Experimental
Intervention: SA-001 (Drug)
H
Experimental
Intervention: SA-001 (Drug)
Outcomes
Primary Outcomes
Change in CFA from baseline to the end of double-blind treatment
Time Frame: 7 days after baseline
Secondary Outcomes
- Stool fat excretion, stool weight, stool frequency, nutritional parameters(7 days after baseline)
Investigators
Study Sites (98)
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