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

NCT ID: NCT01888549

Last Updated: 2016-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-02-29

Brief Summary

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

Detailed Description

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Conditions

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Chronic Cough Caused by Gastroesophageal Reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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arm1-High dose PPI

Group Type EXPERIMENTAL

High-dose PPI

Intervention Type DRUG

:40mg, po(per oral) 2times.day, 8weeks

arm2-standard dose PPI

Group Type ACTIVE_COMPARATOR

standard PPI

Intervention Type DRUG

: 40mg, po(per oral) 1times.day, 8weeks

arm3-placebo

Esomeprazole placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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High-dose PPI

:40mg, po(per oral) 2times.day, 8weeks

Intervention Type DRUG

standard PPI

: 40mg, po(per oral) 1times.day, 8weeks

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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 antireflux procedure 3. previous aerodigestive malignancy or Barrett's oesophagus 4. current smokers or ex-smok-ers (defined 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-inflammatory agent or anticholinesterase drug at time of enrolment
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gangnam severance hospita

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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Park HJ, Park YM, Kim JH, Lee HS, Kim HJ, Ahn CM, Byun MK. Effectiveness of proton pump inhibitor in unexplained chronic cough. PLoS One. 2017 Oct 10;12(10):e0185397. doi: 10.1371/journal.pone.0185397. eCollection 2017.

Reference Type DERIVED
PMID: 29016626 (View on PubMed)

Other Identifiers

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3-2011-0103

Identifier Type: -

Identifier Source: org_study_id

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