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Gut Imaging for Function & Transit in Cystic Fibrosis Study 2

NCT04006873 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-05-24

No results posted yet for this study

Summary

People with Cystic Fibrosis (CF) have problems digesting their food properly. More than 8 in 10 people with CF must take medication to assist their digestion. In spite of this, complications such as bowel blockage occur.

Finding out how already licenced drugs for CF work in the gut is the first step in repurposing medications. Tezacaftor/Ivacaftor with Ivacaftor is a drug combination which corrects the basic defect in CF an has shown improvements on lung function.

The purpose of this study is to evaluate, using Magnetic Resonance Imaging (MRI) and patient-reported outcomes, whether Tezacaftor/Ivacaftor with Ivacaftor has an effect on improving gastrointestinal problems in CF.

Conditions

Interventions

DRUG

Tezacaftor/Ivacaftor + Ivacaftor

As per description in arms.

DRUG

Placebo oral tablet

As per description in arms

Sponsors & Collaborators

  • Vertex Pharmaceuticals Incorporated

    collaborator INDUSTRY

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • Cystic Fibrosis Trust

    collaborator OTHER

  • University of Nottingham

    collaborator OTHER

  • Nottingham University Hospitals Charity

    collaborator UNKNOWN

  • Nottingham University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Alan Smyth, Prof · University of Nottingham

  • Giles Major, Dr · University of Nottingham

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-03
Primary Completion
2020-10-29
Completion
2020-10-29
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Entities

Diseases
Companies

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 NCT04006873 on ClinicalTrials.gov