NCT00006063

Brief Summary

OBJECTIVES: I. Compare the efficacy of enteric coated pancrelipase with bicarbonate (PANCRECARB) capsules versus the patient's usual enteric coated pancreatic enzyme without bicarbonate in decreasing fecal fat and nitrogen losses in patients with cystic fibrosis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 1999

Shorter than P25 for not_applicable

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, 1999

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 1999

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2000

Completed
Last Updated

June 24, 2005

Status Verified

July 1, 2000

First QC Date

July 5, 2000

Last Update Submit

June 23, 2005

Conditions

Cystic Fibrosis

Keywords

cardiovascular and respiratory diseasescystic fibrosisgenetic diseases and dysmorphic syndromesrare disease

Interventions

pancrelipase with bicarbonateDRUG

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- * Clinical diagnosis of cystic fibrosis Duplicate sweat chloride measurements greater than 60 mEq/L on samples collected after pilocarpine iontophoresis * Patients with a history of malabsorption who consume at least 1,000 to 2,500 lipase units/kg/meal --Prior/Concurrent Therapy-- * No concurrent oral antibiotics, antacids, H2 receptor antagonists, or any drugs known to interfere with digestion --Patient Characteristics-- * Weight for height greater than the 5th percentile * No prior meconium ileus with intestinal resection * No known hypersensitivity to pancrelipase or pork protein

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Cystic FibrosisRespiratory Tract DiseasesGenetic Diseases, InbornRare Diseases

Interventions

PancrelipaseBicarbonates

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LipaseCarboxylic Ester HydrolasesEsterasesHydrolasesEnzymesEnzymes and CoenzymesPancreatic ExtractsTissue ExtractsComplex MixturesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsAnionsIonsElectrolytes

Study Officials

  • Mary Sue Brady

    Indiana University School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 5, 2000

First Posted

July 6, 2000

Study Start

July 1, 1999

Study Completion

August 1, 1999

Last Updated

June 24, 2005

Record last verified: 2000-07