NCT01159119

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
terminated

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

July 5, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 9, 2010

Completed
24 days until next milestone

Study Start

First participant enrolled

August 2, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

January 18, 2020

Status Verified

December 1, 2019

Enrollment Period

11 months

First QC Date

July 5, 2010

Last Update Submit

January 13, 2020

Conditions

Chronic Pancreatitis

Keywords

Chronic Abdominal PainExocrine Pancreatic Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Comparing frequency and severity of pain

    Patient diary

    up to 84 days

Secondary Outcomes (1)

  • Changes in fat malabsorption

    up to 124 days

Study Arms (3)

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

EUR-1066-ADRUG

Eur-1066 capsules taken daily for 28 days either during treatment period 1 or treatment period 3.

Also known as: EUR-1066
EUR-1066-A
ZenpepDRUG

Capsules taken for daily for 28 days during treatment period 2

Zenpep
EUR-1066-BDRUG

Eur-1066 capsules taken daily for 28 days either during treatment period 1 or treatment period 3.

Also known as: EUR-1066
EUR-1066-B

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of Chronic Pancreatitis
  • Exocrine Pancreatic Insufficiency
  • Chronic abdominal pain

You may not qualify if:

  • Acute pancreatitis
  • Active alcohol consumption
  • Uncontrolled diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Pancreatitis, ChronicExocrine Pancreatic Insufficiency

Interventions

Pancrelipase

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LipaseCarboxylic Ester HydrolasesEsterasesHydrolasesEnzymesEnzymes and CoenzymesPancreatic ExtractsTissue ExtractsComplex Mixtures

Study Officials

  • Phillip Toskes, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2010

First Posted

July 9, 2010

Study Start

August 2, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

January 18, 2020

Record last verified: 2019-12

Locations

US(1)