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NCT01888549 Clinical Trial

Efficacy of Proton Pump Inhibitor for Chronic Cough Caused by Gastroesophageal Reflux; Double-blind, Placebo-controlled, Randomized Clinical Trial

Chronic Cough Caused by Gastroesophageal Reflux Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01888549
Other study ID # 3-2011-0103
Secondary ID
Status Completed
Phase N/A
First received June 25, 2013
Last updated June 22, 2016
Start date February 2012
Est. completion date February 2016

Study information
Verified date June 2016
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Efficacy of proton pump inhibitor for chronic cough caused by gastroesophageal reflux; double-blind, placebo-controlled, randomized clinical trial

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Both
Age group 19 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• High-dose PPI
:40mg, po(per oral) 2times.day, 8weeks
• standard PPI
: 40mg, po(per oral) 1times.day, 8weeks
• placebo

Locations
Country Name City State
Korea, Republic of Gangnam severance hospita Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary change in LCQ score and cough VAS, comparing PPI-treated group to placebo change in LCQ score after 4 weeks and 8 weeks No
Secondary change in LCQ score and cough VAS, comparing PPI-treated group to placebo change in cough VAS after 4weeks and 8 weeks No