A Study of EUR-1066 in Subjects With Chronic Pancreatitis... | NCT01159119

Studies
A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal Pain

NCT01159119

Sponsor

Forest Laboratories

Status

Terminated

Last Update Posted

Jan 18, 2020Actual

Enrollment

15Estimated

Phase

Phase 1

Conditions

Chronic Pancreatitis

Interventions

EUR-1066-A
Zenpep
EUR-1066-B

Countries

United States

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

Dec 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2, 2010Actual

Primary Completion Date

Jul 1, 2011Actual

Completion Date

Jul 1, 2011Actual

First Submitted Date

Jul 5, 2010

First Submission Date that Met QC Criteria

Jul 7, 2010

First Posted Date

Jul 9, 2010Estimated

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

Jan 13, 2020

Last Update Posted Date

Jan 18, 2020Actual

Name	Class
University of Florida	OTHER

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

The purpose of this study is to evaluate two different treatments in subjects with chronic pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain.

Detailed Description

To evaluate two different preparations of a pancreatic enzyme in subjects with chronic pancreatitis, exocrine pancreatic insufficiency, and chronic abdominal pain.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EUR-1066-A	Experimental	Treatment with Eur-1006-A.	Drug: EUR-1066-A
EUR-1066-B	Experimental	Treatment with Eur-1066-B	Drug: EUR-1066-B
Zenpep	Active Comparator	Control Group: Consist of treatment with Zenpep	Drug: Zenpep

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EUR-1066-A	Drug	Eur-1066 capsules taken daily for 28 days either during treatment period 1 or treatment period 3.	EUR-1066-A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparing frequency and severity of pain	Patient diary	up to 84 days

Secondary Outcomes

Measure	Description	Time Frame
Changes in fat malabsorption	Assess the coefficient of fat absorption	up to 124 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Chronic Pancreatitis
Exocrine Pancreatic Insufficiency
Chronic abdominal pain

Exclusion Criteria:

Acute pancreatitis
Active alcohol consumption
Uncontrolled diabetes

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
Phillip Toskes, MD	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida		Gainesville	Florida	32611	United States

Condition Browse Module

MeSH Terms

ID	Term
D050500	Pancreatitis, Chronic
D010188	Exocrine Pancreatic Insufficiency

Ancestor Terms

ID	Term
D010195	Pancreatitis
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020799	Pancrelipase

Ancestor Terms

ID	Term
D008049	Lipase
D002265	Carboxylic Ester Hydrolases
D004950	Esterases
D006867	Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided