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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02533349

Enrollment

200

Registered

2015-08-26

Start date

2016-05-31

Completion date

2017-01-31

Last updated

2016-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngopharyngeal Reflux Disease

Keywords

laryngopharyngeal reflux disease, prokinetics, proton pump inhibitor

Brief summary

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.

Interventions

DRUGMotilitone

30mg, 1 tablet, 3 times a day

DRUGPantoprazole

40mg, 1 tablet, 1time a day

DRUGPlacebo

30mg, 1 tablet, 3 times a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Reflux symptom index (questionnaire)	1 month after medication	Reflux symptom index is validated questionnaire for laryngopharyngeal reflux disease. It consists of 9 items, and scale of each item ranges from 0 to 5 with maximal total score of 45.
Reflux finding score (scoring of laryngeal stroboscopy finding score)	1 month after medication	Reflux finding score is an 8-item clinical severity scale based on findings during laryngeal stroboscopy. The scale ranges from 0 (no abnormal findings) to a maximum of 26 (worst score possible).

Secondary

Measure	Time frame	Description
Reflux symptom index (questionnaire)	3 months after medication	Reflux symptom index is validated questionnaire for laryngopharyngeal reflux disease. It consists of 9 items, and scale of each item ranges from 0 to 5 with maximal total score of 45.
Reflux finding score (scoring of laryngeal stroboscopy finding score)	3 months after medication	Reflux finding score is an 8-item clinical severity scale based on findings during laryngeal stroboscopy. The scale ranges from 0 (no abnormal findings) to a maximum of 26 (worst score possible).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026