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

Primary Purpose

Pancreatic Insufficiency

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Pancreatin
Placebo
Sponsored by
Abbott Products
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Insufficiency focused on measuring Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Reference ID/Investigator# 45389
  • Site Reference ID/Investigator# 45396
  • Site Reference ID/Investigator# 45390
  • Site Reference ID/Investigator# 54382
  • Site Reference ID/Investigator# 45391
  • Site Reference ID/Investigator# 45388
  • Site Reference ID/Investigator# 45387
  • Site Reference ID/Investigator# 45383
  • Site Reference ID/Investigator# 45382
  • Site Reference ID/Investigator# 45395
  • Site Reference ID/Investigator# 45393

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

CNA, stool fat, stool weight, nutritional, clinical symptomatology, SF-36, BMI

Full Information

First Posted
June 26, 2008
Last Updated
August 16, 2011
Sponsor
Abbott Products
Collaborators
Datamap
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1. Study Identification

Unique Protocol Identification Number
NCT00705978
Brief Title
Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic Pancreatitis
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 Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott Products
Collaborators
Datamap

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Insufficiency
Keywords
Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pancreatin
Intervention Description
Pancreatin with 40000 lipase units per capsule, 2 capsules per main meal (3 main meals) plus 1 capsule per snack (2-3 snacks)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Change in CFA from baseline to the end of double blind treatment
Time Frame
7 days after baseline
Secondary Outcome Measure Information:
Title
CNA, stool fat, stool weight, nutritional, clinical symptomatology, SF-36, BMI
Time Frame
7 days after baseline, and end of open-label period (1 year of open label treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guenter Krause, MD
Organizational Affiliation
Abbott Products
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 45389
City
Bangalore
ZIP/Postal Code
560017
Country
India
Facility Name
Site Reference ID/Investigator# 45396
City
Bhopal
ZIP/Postal Code
462 016
Country
India
Facility Name
Site Reference ID/Investigator# 45390
City
Chennai
ZIP/Postal Code
600096
Country
India
Facility Name
Site Reference ID/Investigator# 54382
City
Cochin
ZIP/Postal Code
682304
Country
India
Facility Name
Site Reference ID/Investigator# 45391
City
Hyderabad
ZIP/Postal Code
500082
Country
India
Facility Name
Site Reference ID/Investigator# 45388
City
Jaipur
ZIP/Postal Code
302001
Country
India
Facility Name
Site Reference ID/Investigator# 45387
City
Kolkatta
ZIP/Postal Code
700054
Country
India
Facility Name
Site Reference ID/Investigator# 45383
City
Mumbai
ZIP/Postal Code
400012
Country
India
Facility Name
Site Reference ID/Investigator# 45382
City
Pune
ZIP/Postal Code
411 004
Country
India
Facility Name
Site Reference ID/Investigator# 45395
City
Pune
ZIP/Postal Code
411013
Country
India
Facility Name
Site Reference ID/Investigator# 45393
City
Trivandrum
ZIP/Postal Code
695607
Country
India

12. IPD Sharing Statement

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

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