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TerminatedNCT01159119EUR-1066Updated Jan 18, 2020

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

A Phase 1 interventional study of EUR-1066-A and Zenpep in Chronic Pancreatitis, sponsored by Forest Laboratories. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-18.

Sponsored by Forest Laboratories (part of AbbVie) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Chronic Pancreatitis

Keywords

  • Chronic Abdominal Pain
  • Exocrine Pancreatic Insufficiency
03

In context

Pancreatitis, Chronic

264 studies on the registry are indexed under Pancreatitis, Chronic; 76 are open to participants now.

This study's planned enrollment of 15 is below the median of 45 across 143 interventional studies indexed under Pancreatitis, Chronic.

Browse Pancreatitis, Chronic studies →

Lead sponsor

Forest Laboratories is the lead sponsor of 168 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

First submitted before Forest Laboratories became part of AbbVie.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Acute pancreatitis
  • Active alcohol consumption
  • Uncontrolled diabetes
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Care provider)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    EUR-1066-A

    Treatment with Eur-1006-A.

    Drug: EUR-1066-A

  • Experimental
    EUR-1066-B

    Treatment with Eur-1066-B

    Drug: EUR-1066-B

  • Active comparator
    Zenpep

    Control Group: Consist of treatment with Zenpep

    Drug: Zenpep

Interventions

  • DrugEUR-1066-A

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

    Also known as: EUR-1066

  • DrugZenpep

    Capsules taken for daily for 28 days during treatment period 2

  • DrugEUR-1066-B

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

    Also known as: EUR-1066

06

What researchers measure

Primary outcomes

  1. Comparing frequency and severity of pain

    Patient diary

    Time frame: up to 84 days

Secondary outcomes

  1. Changes in fat malabsorption

    Assess the coefficient of fat absorption

    Time frame: up to 124 days

07

Study locations

1 site
  • University of Florida
    Gainesville, Florida 32611, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01159119
Responsible party
Sponsor
First posted
Jul 9, 2010
Start date
Aug 2, 2010
Primary completion
Jul 1, 2011
Completion
Jul 1, 2011
Last update
Jan 18, 2020

Study contacts

Phillip Toskes, MD
principal investigator · University of Florida

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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