A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency
- Conditions
- Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
- Interventions
- Drug: Placebo
- Registration Number
- NCT00400842
- Lead Sponsor
- Abbott
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 274
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description L SA-001 - P Placebo - H SA-001 -
- Primary Outcome Measures
Name Time Method Change in CFA from baseline to the end of double-blind treatment 7 days after baseline
- Secondary Outcome Measures
Name Time Method Stool fat excretion, stool weight, stool frequency, nutritional parameters 7 days after baseline
Trial Locations
- Locations (98)
Site Reference ID/Investigator# 59845
🇯🇵Aichi, Japan
Site Reference ID/Investigator# 59933
🇯🇵Aichi, Japan
Site Reference ID/Investigator# 59928
🇯🇵Akita, Japan
Site Reference ID/Investigator# 59983
🇯🇵Amori, Japan
Site Reference ID/Investigator# 59984
🇯🇵Amori, Japan
Site Reference ID/Investigator# 59569
🇯🇵Ehime, Japan
Site Reference ID/Investigator# 59938
🇯🇵Ehime, Japan
Site Reference ID/Investigator# 59571
🇯🇵Fukuoka, Japan
Site Reference ID/Investigator# 59572
🇯🇵Fukuoka, Japan
Site Reference ID/Investigator# 59812
🇯🇵Fukuoka, Japan
Scroll for more (88 remaining)Site Reference ID/Investigator# 59845🇯🇵Aichi, Japan