NCT00217204

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of PANCREASE MT (pancrelipase microtablets) to improve steatorrhea (excessive excretion of fat in feces) in infants and toddlers with cystic fibrosis who have pancreatic insufficiency, and to assess whether the consistency of the microtablets is acceptable for swallowing in infants and toddlers

Trial Health

100
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

May 19, 2011

Status Verified

April 1, 2010

First QC Date

September 13, 2005

Last Update Submit

May 17, 2011

Conditions

Cystic FibrosisSteatorrhea

Keywords

Cystic fibrosisPancreatic insufficiencySteatorrheaFat malabsorptionPancrelipase

Outcome Measures

Primary Outcomes (1)

  • Change in coefficient of fecal fat absorption from baseline to end of study period. Palatability. Percent carbon dioxide expired by 13C-mixed triglyceride breath test measuring exogenous lipase activity.

Secondary Outcomes (1)

  • Clinical Global Impression Severity Subscale. Global Change Subscale. Weight gain/loss. Global Assessment effectiveness. Nitrogen excretion/24 hr. Mean dose of pancrease assessed/day & weight. Mean daily calories, fat intake. Coefficient fat absorption

Interventions

Pancrelipase microtabletsDRUG

Eligibility Criteria

Age6 Months - 30 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of cystic fibrosis
  • Excessive discharge of fat in feces
  • Stable patient requiring pancreatic enzyme therapy

You may not qualify if:

  • No stable antibiotic therapy for small bowel overgrowth
  • No hypersensitivity to pork products
  • No use of prokinetics eg, metoclopramide or cisapride within the last 30 days
  • No nasogastric feeding tube feeding
  • No use of steroids
  • No use of concomitant H2 blockers or proton pump inhibitors as concomitant therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Cystic FibrosisSteatorrheaExocrine Pancreatic Insufficiency

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesMalabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial

    McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

July 1, 2005

Study Completion

February 1, 2006

Last Updated

May 19, 2011

Record last verified: 2010-04