Trial of Proton Pump Inhibitor With Prokinetics or Placebo in Patients With Laryngopharyngeal Reflux Disease

NCT ID: NCT02533349

Last Updated: 2016-06-01

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-01-31

Brief Summary

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Based on meta-analysis of prokinetics trials in laryngopharyngeal reflux disease (LPRD) (Glicksman et al. 2014), well designed study was performed in 4 articles. But, those studies had several problems including inclusion criteria, randomization methods, and placebo medication. They had similar results that prokinetics and proton pump inhibitor (PPI) had synergistic effect for management of LPRD. Therefore, the aim of study is to evaluate the efficacy of prokinetics as an additional medication to proton pump inhibitor by well designed randomized double blind case-control study.

Detailed Description

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Conditions

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Laryngopharyngeal Reflux Disease

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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Proton pump inhibitor + prokinetics

Patient will be prescribed proton pump inhibitor (pantoprazole, 40mg, 1T QD) with prokinetics (Motilitone, 30mg, 1T, TID) for 3months.

Group Type ACTIVE_COMPARATOR

Motilitone

Intervention Type DRUG

30mg, 1 tablet, 3 times a day

Pantoprazole

Intervention Type DRUG

40mg, 1 tablet, 1time a day

Proton pump inhibitor + placebo

Patient will be prescribed proton pump inhibitor (pantoprazole, 40mg, 1T QD) with placebo (Motilitone, 30mg, 1T, TID) for 3months.

Group Type PLACEBO_COMPARATOR

Pantoprazole

Intervention Type DRUG

40mg, 1 tablet, 1time a day

Placebo

Intervention Type DRUG

30mg, 1 tablet, 3 times a day

Interventions

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Motilitone

30mg, 1 tablet, 3 times a day

Intervention Type DRUG

Pantoprazole

40mg, 1 tablet, 1time a day

Intervention Type DRUG

Placebo

30mg, 1 tablet, 3 times a day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age between 20 and 65 years
* Reflux Symptom Index (RSI) \> 7 and, Reflux Finding Score (RFS) \> 13

Exclusion Criteria

* Taken proton pump inhibitor within 3months
* Taken steroid within 3months
* Pregnancy
* Breast feeding
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Man Ki Chung

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Man Ki Chung, MD

Role: primary

82-2-3410-1845

References

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Glicksman JT, Mick PT, Fung K, Carroll TL. Prokinetic agents and laryngopharyngeal reflux disease: Prokinetic agents and laryngopharyngeal reflux disease: a systematic review. Laryngoscope. 2014 Oct;124(10):2375-9. doi: 10.1002/lary.24738. Epub 2014 Jun 10.

Reference Type RESULT
PMID: 24782414 (View on PubMed)

Other Identifiers

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2015-05-007-001

Identifier Type: -

Identifier Source: org_study_id

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