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

Phase 3

Completed

• Conditions: Pancreatic Insufficiency
• Interventions: Drug: Placebo; Drug: Pancreatin

• Registration Number: NCT00705978
• Lead Sponsor: Abbott Products

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-26
• Study First Submitted QC: 2008-06-26
• Study First Posted: 2008-06-27
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-16
• Last Update Posted: 2011-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	Pancreatin	-

Primary Outcome Measures

Name	Time	Method
Change in CFA from baseline to the end of double blind treatment	7 days after baseline

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (11)

Site Reference ID/Investigator# 45390; 🇮🇳 Chennai, India

Site Reference ID/Investigator# 45391; 🇮🇳 Hyderabad, India

Site Reference ID/Investigator# 45395; 🇮🇳 Pune, India

Site Reference ID/Investigator# 45388; 🇮🇳 Jaipur, India

Site Reference ID/Investigator# 45387; 🇮🇳 Kolkatta, India

Site Reference ID/Investigator# 54382; 🇮🇳 Cochin, India

Site Reference ID/Investigator# 45389; 🇮🇳 Bangalore, India

Site Reference ID/Investigator# 45396; 🇮🇳 Bhopal, India

Site Reference ID/Investigator# 45383; 🇮🇳 Mumbai, India

Site Reference ID/Investigator# 45382; 🇮🇳 Pune, India

Site Reference ID/Investigator# 45393; 🇮🇳 Trivandrum, India