CFDB - Cystic Fibrosis DataBase

  1. Home
  2. Database
Search (?)
at least one term
all terms
Advanced search
ongoing trials trial from www.clinicaltrials.gov

A Study to Compare US Marketed Pancrelipase Drug Product With Drug Product Manufactured With a Modernized Process at an Alternate Manufacturing Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis. - Phase 4 - Not yet recruiting

  • Year: 2019
  • Date: May 10, 2019
  • Author: AbbVie
Source

https://ClinicalTrials.gov/show/NCT03924947

Study design (if review, criteria of inclusion for studies)

Interventional - Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment

Participants

Cystic Fibrosis - 12 Years and older   (Child, Adult, Older Adult)

Interventions

Drug: Pancrelipase

Outcome measures

Coefficient of Fat Absorption (CFA)|Stool fat|Coefficient of Nitrogen Absorption (CNA)|Stool weight

Keywords: Adolescent; Adult; Child; Enteric-Coated; Gastrointestinal Agents; Gastrointestinal Diseases; Microspheres; pharmacological_intervention; Pancreas insufficiency; Pancreatic Diseases; Pancreatic Enzyme Replacement Therapy; Supplementation; Malabsorption; Nutrition Disorders; Home; Pancrelipase;