Official Title: “A One Week Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study With Creon 40,000 MMS in Subjects With Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis, Followed by an Open-Label Long-Term Extension”

This study will provide efficacy data for Creon 40,000 in CP subjects as well as long-term safety data. During the long-term treatment with Creon 40,000 nutritional parameters will be assessed and correlated with CFA.

Study Type: Interventional

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

Study Primary Completion Date: March 2010

Intervention(s) in this Clinical Trial

• Drug: Pancreatin
  • Pancreatin with 40000 lipase units per capsule, 2 capsules per main meal (3 main meals) plus 1 capsule per snack (2-3 snacks)
• Drug: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

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, clinical symptomatology, SF-36, BMI
  • Time Frame: 7 days after baseline, and end of open-label period (1 year of open label treatment)
    Safety Issue?: No

Inclusion Criteria:

• Pancreatic exocrine insufficiency has to be proven (in medical history) by a pancreatic function test
• Chronic pancreatitis has to be proven (in medical history) by CT, ERCP, plain film with pancreatic calcifications, ultrasonography (calcifications,duct dilatation) and /or histology.
• Females must be non-lactating and either be of non-childbearing potential or if of childbearing potential, agree to practice effective barrier contraceptive methods, use an intrauterine device (IUD) or use birth control pills or equivalent injectable contraceptive. The subject must have been practicing the selected method of birth control for at least 3 months prior to Visit 1 (Day -14).
• Subjects with a pathological stool fat during run in period (> 10g/24 h)

Exclusion Criteria:

• Ileus or acute abdomen
• Any type of malignancy involving the digestive tract in the last 5 years
• Presence of pseudo pancreatic cysts ≥ 4 cm
• Current excessive intake of alcohol or drug abuse
• Hypersensitivity vs porcine proteins / pancreatin

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  

Overall Contact: Gregor Eibes  gregor.eibes@solvay.com

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00705978

Study ID Number: S245.4.009

ClinicalTrials.gov Identifier: NCT00705978

Health Authority: India: Ministry of Health