NCT00535756

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2008

Typical duration for phase_4

Geographic Reach
4 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

August 18, 2011

Status Verified

August 1, 2011

Enrollment Period

3.2 years

First QC Date

September 25, 2007

Last Update Submit

August 16, 2011

Conditions

Pancreatic Insufficiency

Keywords

Pancreatic Exocrine Insufficiency After Pancreatic Surgery

Outcome Measures

Primary Outcomes (1)

  • Change in CFA from baseline to the end of double blind treatment

    7 days after baseline

Secondary Outcomes (1)

  • 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)

Study Arms (2)

1

EXPERIMENTAL
Drug: Creon

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

CreonDRUG

3 capsules Creon with 25000 lipase units per main meal (3 main meals) plus 2 capsules per snack (2-3 snacks)

1
PlaceboDRUG

Placebo

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pancreatic exocrine insufficiency has to be proven (in medical history) by the following criteria:
  • Direct or indirect pancreatic function test (except stool fat excretion) and
  • Steatorrhoea: stool fat \> 15 g/day (using van de Kamer method)
  • Proven chronic pancreatitis
  • Females of child-bearing potential must agree to continue using a medically acceptable method of birth control

You may not qualify if:

  • Subjects in an unstable situation (catabolic) after pancreatic surgery
  • Ileus or acute abdomen
  • Current excessive intake of alcohol or drug abuse
  • Hypersensitivity vs porcine proteins / pancreatin
  • Subjects taking digestive enzyme preparations have to stop them before start of the run-in period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Site Reference ID/Investigator# 45022

Rousse, 7002, Bulgaria

Location

Site Reference ID/Investigator# 45020

Sofia, 1233, Bulgaria

Location

Site Reference ID/Investigator# 45026

Greifswald, MV 17475, Germany

Location

Site Reference ID/Investigator# 45025

Hamburg, 20246, Germany

Location

Site Reference ID/Investigator# 45027

Heidelberg, 69120, Germany

Location

Site Reference ID/Investigator# 45024

Munich, 81675, Germany

Location

Site Reference ID/Investigator# 45126

Békéscsaba, 5600, Hungary

Location

Site Reference ID/Investigator# 45121

Budaörs, 2040, Hungary

Location

Site Reference ID/Investigator# 45127

Dunaújváros, 2400, Hungary

Location

Site Reference ID/Investigator# 45115

Gyula, 5700, Hungary

Location

Site Reference ID/Investigator# 45116

Sopron, 9400, Hungary

Location

Site Reference ID/Investigator# 45114

Szeged, 6720, Hungary

Location

Site Reference ID/Investigator# 45130

Bologna, 40138, Italy

Location

Site Reference ID/Investigator# 45129

Padua, 35128, Italy

Location

Site Reference ID/Investigator# 45128

Verona, 37126, Italy

Location

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency

Interventions

Pancrelipase

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

LipaseCarboxylic Ester HydrolasesEsterasesHydrolasesEnzymesEnzymes and CoenzymesPancreatic ExtractsTissue ExtractsComplex Mixtures

Study Officials

  • Guenter Krause, MD

    Abbott Products

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 25, 2007

First Posted

September 26, 2007

Study Start

April 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

August 18, 2011

Record last verified: 2011-08

Locations

BU(2)IT(3)DE(4)HU(6)