NCT00957151

Brief Summary

The objective is to evaluate the dietary nitrogen assimilation and metabolic utilisation capability of patients with chronic pancreatitis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2004

Status
completed

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

Study Start

First participant enrolled

April 1, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2009

Completed
Last Updated

August 12, 2009

Status Verified

August 1, 2009

Enrollment Period

1.3 years

First QC Date

August 11, 2009

Last Update Submit

August 11, 2009

Conditions

Chronic Pancreatitis

Keywords

chronic pancreatitisexocrine pancreatic insufficiencyenzyme therapypatients with chronic pancreatitis and exocrine pancreatic insufficiencytaking enzyme replacement therapy

Outcome Measures

Primary Outcomes (1)

  • To measure digestive and metabolic assimilation of dietary proteins in patients with chronic pancreatitis

Secondary Outcomes (1)

  • To determine the efficacy of enzyme therapy

Interventions

CreonDRUG

Eligibility Criteria

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

You may qualify if:

  • subjects with chronic pancreatitis and taking enzyme replacement therapy

You may not qualify if:

  • patients with hepatic impairment
  • patients allergic to dairy proteins
  • urinary incontinence affecting the measurement of nitrogen metabolism
  • digestive disorder affecting the absorption of nutrients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

  • Robert Benamouzig, Pr

    Department of Gastroenterology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2009

First Posted

August 12, 2009

Study Start

April 1, 2004

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

August 12, 2009

Record last verified: 2009-08