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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

• Drug: Pancrelipase delayed release capsule
  • 24,000 unit capsule
• Drug: Placebo Comparator
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Placebo Comparator: B

Primary Measures

• Change in CFA from baseline to the end of double blind treatment.
  • Time Frame: 7 days after baseline
    Safety Issue?: No

Secondary 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).
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Solvay Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Global Clinical Director Solvay Study Director Solvay Pharmaceuticals  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00414908

Study ID Number: S245.3.124

ClinicalTrials.gov Identifier: NCT00414908

Health Authority: United States: Food and Drug Administration