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PERT for Treatment of Exocrine Pancreatic Insufficiency in Patients With Unresectable Pancreatic Cancer

NCT02985801 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-03-15

Study results available
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Summary

Does pancreas enzyme replacement (PERT) decrease weight loss and improve quality of life in patients with unresectable pancreatic cancer?

Conditions

Interventions

DRUG

Pancrelipase

Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units

DRUG

Placebo Oral Capsule

Placebo Oral Capsule

Sponsors & Collaborators

  • Digestive Care, Inc.

    collaborator INDUSTRY

  • Massimo Raimondo, M.D.

    lead OTHER

Principal Investigators

  • Massimo Raimondo, MD · Professor of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2019-04-30
Completion
2019-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02985801 on ClinicalTrials.gov