Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic Pancreatitis
Information source: Solvay Pharmaceuticals
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreatic Insufficiency
Intervention: Pancreatin (Drug); Placebo (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:
Gregor Eibes, Email: gregor.eibes@solvay.com
Summary
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.
Clinical Details
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
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, clinical symptomatology, SF-36, 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 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
Locations and Contacts
Gregor Eibes, Email: gregor.eibes@solvay.com
Site 01, New Delhi, India; Not yet recruiting
Site 02, Mumbai, India; Not yet recruiting
Site 03, Kolkatta, India; Not yet recruiting
Site 04, Kochin, India; Recruiting
Site 05, Jaipur, India; Recruiting
Site 06, Bangalore, India; Not yet recruiting
Site 07, Chennai, India; Recruiting
Site 08, Hyderabaad, India; Recruiting
Site 09, Pune, India; Recruiting
Site 10, Hyderabaad, India; Not yet recruiting
Additional Information
Starting date: July 2008
Ending date: March 2010
Last updated: January 29, 2009
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