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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01262352 |
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Date of registration:
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15/12/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study of the Effect of Ivacaftor on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D Mutation
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Scientific title:
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effect of VX-770 on Lung Clearance Index in Subjects With Cystic Fibrosis, the G551D Mutation, and FEV1 >90% Predicted |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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21 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01262352 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Ireland
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United Kingdom
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United States
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Contacts
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Name:
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Felix Ratjen |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Hospital for Sick Children |
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Name:
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Jane Davies |
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Address:
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Telephone:
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Email:
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Affiliation:
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Royal Brompton Hospital and Imperial College |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female subjects with confirmed diagnosis of CF
- Must have the G551D-CFTR mutation in at least 1 allele
- FEV1 >90% of predicted normal for age, gender, and height
Exclusion Criteria:
- Ongoing participation in another therapeutic clinical study or prior participation in
an investigational drug study within the 30 days prior to screening
- Use of inhaled hypertonic saline treatment within 2 weeks of the Period 1, Day 1 visit
Age minimum:
6 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Placebo
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Drug: Ivacaftor
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Primary Outcome(s)
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Absolute Change From Baseline in Lung Clearance Index (LCI)
[Time Frame: Baseline through Day 29]
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Secondary Outcome(s)
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Absolute Change From Baseline in Percent Predicted FEV1
[Time Frame: Baseline through Day 29]
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Change From Baseline in CF Questionnaire-Revised (CFQ-R) Score (Respiratory Domain Score, Pooled)
[Time Frame: Baseline through Day 29]
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Change From Baseline in Sweat Chloride
[Time Frame: Baseline through Day 29]
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Secondary ID(s)
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VX10-770-106
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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