Study Investigating a Pancreatic Enzyme in Patients With PEI Due to CP and PX Pancreatic Insufficiency Due to Chronic Pancreatitis
Information source: Solvay Pharmaceuticals
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Pancreatitis; Pancreatectomy; Pancreatic Exocrine Insufficiency
Intervention: Pancrelipase delayed release capsule (Drug); Placebo Comparator (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Solvay Pharmaceuticals Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals
Overall contact:
Joachim Luszick, Email: joachim.luszick@solvay.com
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Change in CFA from baseline to the end of double blind treatment.
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Joachim Luszick, Email: joachim.luszick@solvay.com
Site 23, Sofia, Bulgaria; Recruiting
Site 27, Warsaw, Poland; Recruiting
Site 19, San Juan, Puerto Rico; Not yet recruiting
Site 25, Leningrad, Russian Federation; Recruiting
Site 26, Belgrade, Serbia; Recruiting
Site 24, Cape Town, South Africa; Not yet recruiting
Site 28, Kiev, Ukraine; Recruiting
Site 9, Scottsdale, Arizona, United States; Terminated
Site 22, Bristol, Connecticut, United States; Terminated
Site 7, Tampa, Florida, United States; Recruiting
Site 6, Atlanta, Georgia, United States; Recruiting
Site 17, Chicago, Illinois, United States; Not yet recruiting
Site 30, Maywood, Illinois, United States; Not yet recruiting
Site 14, Indianapolis, Indiana, United States; Recruiting
Site 15, Kansas City, Kansas, United States; Not yet recruiting
Site 16, Lexington, Kentucky, United States; Recruiting
Site 12, New Orleans, Louisiana, United States; Recruiting
Site 3, Boston, Massachusetts, United States; Not yet recruiting
Site 2, Ann Arbor, Michigan, United States; Not yet recruiting
Site 29, Grand Rapids, Michigan, United States; Not yet recruiting
Site 1, Tupelo, Mississippi, United States; Recruiting
Site 5, St. Louis, Missouri, United States; Not yet recruiting
Site 8, Cedar Knolls, New Jersey, United States; Not yet recruiting
Site 4, Rutherford College, North Carolina, United States; Terminated
Site 20, Boone, North Carolina, United States; Not yet recruiting
Site 10, Cincinnati, Ohio, United States; Terminated
Site 11, Cleveland, Ohio, United States; Terminated
Site 21, Pittsburgh, Pennsylvania, United States; Recruiting
Site 13, Dallas, Texas, United States; Recruiting
Site 18, Richmond, Virginia, United States; Recruiting
Additional Information
Starting date: October 2007
Ending date: November 2008
Last updated: July 1, 2008
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