Creon 40,000 for Treatment of PEI (Pancreatic Exocrine In... | NCT00705978

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

NCT00705978

Sponsor

Abbott Products

Status

Completed

Last Update Posted

Aug 18, 2011Estimated

Enrollment

62Actual

Phase

Phase 3

Conditions

Pancreatic Insufficiency

Interventions

Pancreatin
Placebo

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Jun 26, 2008

First Submission Date that Met QC Criteria

Jun 26, 2008

First Posted Date

Jun 27, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2011

Last Update Posted Date

Aug 18, 2011Estimated

Name	Class
Datamap	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: Pancreatin
2	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pancreatin	Drug	Pancreatin with 40000 lipase units per capsule, 2 capsules per main meal (3 main meals) plus 1 capsule per snack (2-3 snacks)	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in CFA from baseline to the end of double blind treatment		7 days after baseline

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guenter Krause, MD	Abbott Products	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Site Reference ID/Investigator# 45389		Bangalore		560017	India
Site Reference ID/Investigator# 45396

ID	Term
D010188	Exocrine Pancreatic Insufficiency

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D010194	Pancreatin

Ancestor Terms

ID	Term
D006867	Hydrolases
D004798	Enzymes
D045762	Enzymes and Coenzymes
D010184	Pancreatic Extracts

Browse Leaves

Not provided

Browse Branches

Not provided