A Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Pancreatic Exocrine Insufficiency
This study has been completed.
Sponsor:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00401076
First received: November 16, 2006
Last updated: July 28, 2011
Last verified: July 2011
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Purpose
This study is to evaluate the safety of 3.0 g/day of SA-001 (to be flexibly increased or decreased with the range from 1.5 g/day to 6.0 g/day), which will orally be administered for 52 weeks to patients with pancreatic exocrine insufficiency caused by chronic pancreatitis in the non-compensatory stage or by pancreatectomy.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreatic Exocrine Insufficiency, Chronic Pancreatitis, Pancreatectomy |
Drug: SA-001 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A One-year Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Patients With Pancreatic Exocrine Insufficiency Caused by Chronic Pancreatitis or by Pancreatectomy |
Resource links provided by NLM:
Genetics Home Reference related topics:
hereditary pancreatitis
MedlinePlus related topics:
Pancreatitis
U.S. FDA Resources
Further study details as provided by Abbott:
Primary Outcome Measures:
- Safety of long-term use of 3.0 g/day SA 001 (12 capsules/day), flexibly increased or decreased within the range of 1.5 g/day SA 001 (6 capsules/day) to 6.0 g/day SA-001 (24 capsules/day) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Efficacy data (nutritional evaluation items) of 3.0 g/day SA-001 (12 capsules/day), flexibly increased or decreased within the range of 1.5 g/day SA 001 (6 capsules/day) to 6.0 g/day SA-001 (24 capsules/day) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 80 |
| Study Start Date: | July 2008 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: SA-001
0.25 g of SA-001 pellets/capsule, 12 capsules/day for 52 weeks
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria Subjects who complete the S245.3.122 clinical study (excluding discontinued subjects).
Exclusion Criteria Subjects who are assessed to be inappropriate for continuing long-term use of SA-001, at the discretion of the investigator or the sub-investigator, because they experienced adverse drug reactions in the S245.3.122 clinical study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00401076
Locations
| Japan | |
| Site Reference ID/Investigator# 45297 | |
| Fukuoka, Japan | |
| Site Reference ID/Investigator# 45211 | |
| Fukuoka, Japan | |
| Site Reference ID/Investigator# 45279 | |
| Hiroshima, Japan | |
| Site Reference ID/Investigator# 45220 | |
| Hiroshima, Japan | |
| Site Reference ID/Investigator# 45223 | |
| Hokkaido, Japan | |
| Site Reference ID/Investigator# 45303 | |
| Hokkaido, Japan | |
| Site Reference ID/Investigator# 45091 | |
| Hyogo, Japan | |
| Site Reference ID/Investigator# 45213 | |
| Kanagawa, Japan | |
| Site Reference ID/Investigator# 45110 | |
| Kanagawa, Japan | |
| Site Reference ID/Investigator# 45207 | |
| Kyoto, Japan | |
| Site Reference ID/Investigator# 45111 | |
| Miyagi, Japan | |
| Site Reference ID/Investigator# 45282 | |
| Miyagi, Japan | |
| Site Reference ID/Investigator# 45283 | |
| Nagasaki, Japan | |
| Site Reference ID/Investigator# 45106 | |
| Osaka, Japan | |
| Site Reference ID/Investigator# 45242 | |
| Sapporo, Japan | |
| Site Reference ID/Investigator# 45281 | |
| Tokyo, Japan | |
| Site Reference ID/Investigator# 45299 | |
| Yamaguchi, Japan | |
Sponsors and Collaborators
Abbott
Investigators
| Study Director: | Toshiaki Yamaguchi, BS Pharm | Abbott |
More Information
No publications provided
| Responsible Party: | Toshiaki Yamaguchi, Sr. Clinical Project Manager, Abbott |
| ClinicalTrials.gov Identifier: | NCT00401076 History of Changes |
| Other Study ID Numbers: | S245.3.123 |
| Study First Received: | November 16, 2006 |
| Last Updated: | July 28, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Abbott:
|
SA-001 Pancreatic Exocrine Insufficiency Chronic Pancreatitis Pancreatectomy |
Additional relevant MeSH terms:
|
Pancreatitis Pancreatitis, Chronic Pancreatic Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013