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A Open-Label Study to Assess the Safety of Oral Long-Term Use of SA-001 in Pancreatic Exocrine Insufficiency

This study is currently recruiting participants.
Verified by Solvay Pharmaceuticals, September 2008

Sponsored by: Solvay Pharmaceuticals
Information provided by: Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00401076
  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 III

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Adverse events, vital signs, safety laboratory parameters [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Nutritional parameters [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   75
Study Start Date:   September 2007
Estimated Study Completion Date:   February 2010
Estimated Primary Completion Date:   February 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental Drug: SA-001
0.25 g of SA-001 pellets/capsule, 12 capsules/day for 7 days

  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 S2453122 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 subinvestigator, because they experienced adverse drug reactions in the S2453122 clinical study
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401076

Contacts
Contact: Toshiaki Yamaguchi     Toshiaki.Yamaguchi@solvay.com    

Show 68 study locations  Show 68 Study Locations

Sponsors and Collaborators
Solvay Pharmaceuticals

Investigators
Study Director:     Global Clinical Director Solvay     Solvay Pharmaceuticals    
  More Information


Responsible Party:   Solvay Pharmaceuticals ( Toshiaki Yamaguchi )
Study ID Numbers:   S245.3.123
First Received:   November 16, 2006
Last Updated:   September 25, 2008
ClinicalTrials.gov Identifier:   NCT00401076
Health Authority:   Japan: Ministry of Health, Labor and Welfare

Keywords provided by Solvay Pharmaceuticals:
SA-001  
Pancreatic Exocrine Insufficiency  
Chronic Pancreatitis  
Pancreatectomy  

Study placed in the following topic categories:
Digestive System Diseases
Pancreatic Diseases
Pancreatitis
Pancreatitis, Chronic

ClinicalTrials.gov processed this record on October 10, 2008




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