Creon After Pancreatic Surgery

Phase 4

Completed

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

• Registration Number: NCT00535756
• Lead Sponsor: Abbott Products

Brief Summary

This study will provide efficacy data for Creon 25000 MMS in PS patients as well as long-term safety data. During the long-term treatment with Creon 25000 nutritional parameters will be assessed and correlated with CFA

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-09-25
• Study First Submitted QC: 2007-09-25
• Study First Posted: 2007-09-26
• Study Start: 2008-04
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-16
• Last Update Posted: 2011-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	Creon	-

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 parameters, clinical symptomatology, SF-36, BMI	7 days after baseline, and end of open-label period (1 year of open label treatment)

Trial Locations

Locations (15)

Site Reference ID/Investigator# 45020; 🇧🇬 Sofia, Bulgaria

Site Reference ID/Investigator# 45024; 🇩🇪 Munich, Germany

Site Reference ID/Investigator# 45130; 🇮🇹 Bologna, Italy

Site Reference ID/Investigator# 45128; 🇮🇹 Verona, Italy

Site Reference ID/Investigator# 45022; 🇧🇬 Ruse, Bulgaria

Site Reference ID/Investigator# 45129; 🇮🇹 Padova, Italy

Site Reference ID/Investigator# 45027; 🇩🇪 Heidelberg, Germany

Site Reference ID/Investigator# 45025; 🇩🇪 Hamburg, Germany

Site Reference ID/Investigator# 45126; 🇭🇺 Bekescsaba, Hungary

Site Reference ID/Investigator# 45121; 🇭🇺 Budaors, Hungary

Site Reference ID/Investigator# 45115; 🇭🇺 Gyula, Hungary

Site Reference ID/Investigator# 45116; 🇭🇺 Sopron, Hungary

Site Reference ID/Investigator# 45127; 🇭🇺 Dunaujvaros, Hungary

Site Reference ID/Investigator# 45114; 🇭🇺 Szeged, Hungary

Site Reference ID/Investigator# 45026; 🇩🇪 Greifswald, Germany