Study Investigating a Pancreatic Enzyme in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Chronic Pancreatitis (CP) and PX Pancreatic Insufficiency Due to Chronic Pancreatitis - Full Text View

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00414908

Purpose

This study will assess the effect of pancrelipase delayed release capsules on fat and nitrogen absorption in subjects with PEI due to Chronic Pancreatitis. The QoL will also be assessed. Safety data will be generated in the open-label extension period.

Condition	Intervention	Phase
Chronic Pancreatitis Pancreatectomy Pancreatic Exocrine Insufficiency	Drug: Pancrelipase delayed release capsule Drug: Placebo Comparator	Phase III

Drug Information available for: Pancrelipase Ultrase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Change in CFA from baseline to the end of double blind treatment. [ Time Frame: 7 days after baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CNA, stool fat, stool weight, nutritional parameters (triglycerides, LDL, HDL, retinol-binding proteins, pre-albumin, cholesterol), clinical symptomatology (stool frequency, stool consistency, abdominal pain, flatulence, appetite), Quality of life, BMI [ Time Frame: 7 days after baseline, and end of open-label period (6 months of open-label treatment). ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	52
Study Start Date:	October 2007
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Pancrelipase delayed release capsule 24,000 unit capsule
B: Placebo Comparator	Drug: Placebo Comparator Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Pancreatic exocrine insufficiency has to be proven (in medical history) by the following criteria:

Direct or indirect pancreatic function test (except stool fat excretion) or Clinical signs of severe steatorrhoea that resolved upon administration of pancreatic supplementation.
Total stool fat > 40 g over 4 days (using van de Kamer method)
Proven chronic pancreatitis
Females of child-bearing potential must agree to continue using a medically acceptable method of birth control

Exclusion Criteria:

Ileus or acute abdomen
Any type of malignancy involving the digestive tract in the last 5 years
Presence of pseudo-pancreatic cyst ≥ 4
Continued excessive intake of alcohol or drug abuse
Known infection with HIV

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414908

Show 29 Study Locations

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

Responsible Party:	Solvay Pharmaceuticals ( Gregor Eibes )
Study ID Numbers:	S245.3.124, 2004-000227-15
Study First Received:	December 21, 2006
Last Updated:	November 28, 2008
ClinicalTrials.gov Identifier:	NCT00414908
Health Authority:	United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:

Chronic Pancreatitis
Pancreatectomy
Pancreatic Exocrine Insufficiency

Study placed in the following topic categories:

Digestive System Diseases
Pancreatic Diseases
Pancrelipase

Exocrine Pancreatic Insufficiency
Pancreatitis
Pancreatitis, Chronic

Additional relevant MeSH terms:

Therapeutic Uses
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009