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

Primary Purpose

Laryngopharyngeal Reflux Disease

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Motilitone
Pantoprazole
Placebo
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laryngopharyngeal Reflux Disease focused on measuring laryngopharyngeal reflux disease, prokinetics, proton pump inhibitor

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Proton pump inhibitor + prokinetics

Proton pump inhibitor + placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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.
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).

Full Information

First Posted
August 4, 2015
Last Updated
May 29, 2016
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02533349
Brief Title
Trial of Proton Pump Inhibitor With Prokinetics or Placebo in Patients With Laryngopharyngeal Reflux Disease
Official Title
Randomized Controlled Trial of Proton Pump Inhibitor With Prokinetics or Placebo in Patients With Laryngopharyngeal Reflux Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngopharyngeal Reflux Disease
Keywords
laryngopharyngeal reflux disease, prokinetics, proton pump inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Proton pump inhibitor + prokinetics
Arm Type
Active Comparator
Arm Description
Patient will be prescribed proton pump inhibitor (pantoprazole, 40mg, 1T QD) with prokinetics (Motilitone, 30mg, 1T, TID) for 3months.
Arm Title
Proton pump inhibitor + placebo
Arm Type
Placebo Comparator
Arm Description
Patient will be prescribed proton pump inhibitor (pantoprazole, 40mg, 1T QD) with placebo (Motilitone, 30mg, 1T, TID) for 3months.
Intervention Type
Drug
Intervention Name(s)
Motilitone
Intervention Description
30mg, 1 tablet, 3 times a day
Intervention Type
Drug
Intervention Name(s)
Pantoprazole
Intervention Description
40mg, 1 tablet, 1time a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
30mg, 1 tablet, 3 times a day
Primary Outcome Measure Information:
Title
Reflux symptom index (questionnaire)
Description
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.
Time Frame
1 month after medication
Title
Reflux finding score (scoring of laryngeal stroboscopy finding score)
Description
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).
Time Frame
1 month after medication
Secondary Outcome Measure Information:
Title
Reflux symptom index (questionnaire)
Description
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.
Time Frame
3 months after medication
Title
Reflux finding score (scoring of laryngeal stroboscopy finding score)
Description
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).
Time Frame
3 months after medication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Man Ki Chung, MD
Phone
82-2-3410-1845
Email
manki.chung@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
24782414
Citation
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.
Results Reference
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Trial of Proton Pump Inhibitor With Prokinetics or Placebo in Patients With Laryngopharyngeal Reflux Disease

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