Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic Pancreatitis

Pancreatic Insufficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00705978
• Other study ID #: S245.4.009
• Status: Completed
• Phase: Phase 3
• First received: June 26, 2008
• Last updated: August 16, 2011
• Start date: June 2008
• Est. completion date: May 2010

Study information

• Verified date: August 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Exocrine Pancreatic Insufficiency
• Pancreatic Insufficiency
• Pancreatitis
• Pancreatitis, Chronic

Intervention

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)
• Placebo
placebo

Locations

Country	Name	City	State
India	Site Reference ID/Investigator# 45389	Bangalore
India	Site Reference ID/Investigator# 45396	Bhopal
India	Site Reference ID/Investigator# 45390	Chennai
India	Site Reference ID/Investigator# 54382	Cochin
India	Site Reference ID/Investigator# 45391	Hyderabad
India	Site Reference ID/Investigator# 45388	Jaipur
India	Site Reference ID/Investigator# 45387	Kolkatta
India	Site Reference ID/Investigator# 45383	Mumbai
India	Site Reference ID/Investigator# 45382	Pune
India	Site Reference ID/Investigator# 45395	Pune
India	Site Reference ID/Investigator# 45393	Trivandrum

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Products	Datamap

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CFA from baseline to the end of double blind treatment		7 days after baseline	No
Secondary	CNA, stool fat, stool weight, nutritional, clinical symptomatology, SF-36, BMI		7 days after baseline, and end of open-label period (1 year of open label treatment)	No