NCT02533349

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 26, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

June 1, 2016

Status Verified

May 1, 2016

Enrollment Period

7 months

First QC Date

August 4, 2015

Last Update Submit

May 29, 2016

Conditions

Laryngopharyngeal Reflux Disease

Keywords

laryngopharyngeal reflux diseaseprokineticsproton pump inhibitor

Outcome Measures

Primary Outcomes (2)

  • Reflux symptom index (questionnaire)

    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.

    1 month after medication

  • Reflux finding score (scoring of laryngeal stroboscopy finding score)

    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).

    1 month after medication

Secondary Outcomes (2)

  • Reflux symptom index (questionnaire)

    3 months after medication

  • Reflux finding score (scoring of laryngeal stroboscopy finding score)

    3 months after medication

Study Arms (2)

Proton pump inhibitor + prokinetics

ACTIVE COMPARATOR

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

Drug: MotilitoneDrug: Pantoprazole

Proton pump inhibitor + placebo

PLACEBO COMPARATOR

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

Drug: PantoprazoleDrug: Placebo

Interventions

MotilitoneDRUG

30mg, 1 tablet, 3 times a day

Proton pump inhibitor + prokinetics
PantoprazoleDRUG

40mg, 1 tablet, 1time a day

Proton pump inhibitor + placeboProton pump inhibitor + prokinetics
PlaceboDRUG

30mg, 1 tablet, 3 times a day

Proton pump inhibitor + placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Taken proton pump inhibitor within 3months
  • Taken steroid within 3months
  • Pregnancy
  • Breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 135-710, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 24782414RESULT

MeSH Terms

Interventions

Pantoprazole

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 4, 2015

First Posted

August 26, 2015

Study Start

May 1, 2016

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

June 1, 2016

Record last verified: 2016-05

Locations

KR(1)