|
Main
|
|
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. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
4 July 2016 |
|
Main ID: |
NCT01888549 |
|
Date of registration:
|
25/06/2013 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Efficacy of Proton Pump Inhibitor for Chronic Cough Caused by Gastroesophageal Reflux; Double-blind, Placebo-controlled, Randomized Clinical Trial
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
February 2012 |
|
Target sample size:
|
48 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01888549 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Korea, Republic of
| | | | | | | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
ages of 18 and 70 years had chronic cough of >8 weeks in duration
Exclusion Criteria:
1. abnormal chest X ray, PNS view 2. previous surgical or endoscopic antire?ux procedure
3. previous aerodigestive malignancy or Barrett's oesophagus 4. current smokers or
ex-smok-ers (de?ned as those who quit smoking <3 months prior to study enrolment or those
who have quit, but have a 20 pack year smoking history) 5. Malignancy History (lung
cancer, esophageal cancer etc.) 6. upper respiratory infection within 8 weeks of study
enrolment 7. currently using a PPI, H2 blocker, beta-blocker, angiotensin-converting
enzyme inhibitor, corticosteroid, methylxanthine, inhaled beta-agonist, anti-in?ammatory
agent or anticholinesterase drug at time of enrolment
Age minimum:
19 Years
Age maximum:
70 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Chronic Cough Caused by Gastroesophageal Reflux
|
|
Intervention(s)
|
|
Drug: placebo
|
|
Drug: standard PPI
|
|
Drug: High-dose PPI
|
|
Primary Outcome(s)
|
|
change in LCQ score and cough VAS, comparing PPI-treated group to placebo
[Time Frame: change in LCQ score after 4 weeks and 8 weeks]
|
|
Secondary Outcome(s)
|
|
change in LCQ score and cough VAS, comparing PPI-treated group to placebo
[Time Frame: change in cough VAS after 4weeks and 8 weeks]
|
|
Secondary ID(s)
|
|
3-2011-0103
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|