A Phase 3 interventional study of SA-001 and SA-001 in Exocrine Pancreatic Insufficiency, Chronic Pancreatitis, sponsored by Abbott. Completed at 98 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2011-07-28.
Sponsored by Abbott · Phase 3, Interventional, and Treatment
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.
752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.
This study's enrollment of 274 is above the median of 80 across 448 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.
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Exclusion Criteria
Drug: SA-001
Drug: SA-001
Drug: Placebo
0.25 g of SA-001 pellets/capsule, 12 capsules/day for 7 days
0.25 g of SA-001 pellets/capsule, 6 capsules/day for 7 days
Placebo
Change in CFA from baseline to the end of double-blind treatment
Time frame: 7 days after baseline
Stool fat excretion, stool weight, stool frequency, nutritional parameters
Time frame: 7 days after baseline
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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