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CompletedNCT00729339Updated May 13, 2009

Role of Mosapride in Patients With Gastroesophageal Reflux Disease

A Phase 4 interventional study of mosapride for the first month and placebo for the 2nd month and placebo for the first and mosapride for the second month in Gastroesophageal Reflux Disease, sponsored by Lotung Poh-Ai Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2009-05-13.

Sponsored by Lotung Poh-Ai Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
114
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

Gastroesophageal reflux disease (GERD) is a very common disease in the Western World. In Taiwan, this disease is increasing gradually because the investigators' eating style is closing to Western world.

Proton pump is the main drug for patients with GERD in the past two decades. Prokinetic agent is an important adjuvant to the therapy of GERD. This study aims to evaluate the role of prokinetic agent in the management of GERD.

Read the detailed description

This is a randomized, double-blind, cross-over study. FSSG is obtained at the beginning, one month and two months of the study.

This study plans to enroll 100 patients with symptoms of GERD (acid regurgitation, belching, dysphagia). After receiving endoscopic examination, a frequent scale for the symptoms of gastroesophageal reflux disease (FSSG) is obtained from these patients. Fifty patients receive lansoprazole 30 mg once plus mosapride 5 mg tid daily in the first month; and lansoprazole 30 mg once plus placebo tid daily in the second month. Another fifty patients receive lansoprazole 30 mg once plus placebo tid daily in the first month; and lansoprazole 30 mg once plus mosapride 5 mg tid daily in the second month.

02

Conditions studied

  • Gastroesophageal Reflux Disease

Keywords

  • Gastroesophageal reflux disease
  • Mosapride
  • Lansoprazole
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 114 is above the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Lotung Poh-Ai Hospital is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Aged between 18 and 90 years old
  • Outpatients
  • Characteristic GERD symptoms: acid regurgitation, heart burn, or belching
  • Erosive esophagitis on upper digestive endoscopy, based on Los Angeles classification

Exclusion criteria

Exclusion Criteria:

  • History of allergy to lansoprazole or mosapride
  • Pregnant or lactating women
  • Uremia
  • Decompensated liver disease
  • Age under 18 and over 90 years-old
  • Lack of informed consent
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
114 participants (actual)

Study arms

  • Active comparator
    1

    lansoprazole plus mosapride for the first month, and followed by lansoprazole plus placebo for the second month

    Drug: mosapride for the first month and placebo for the 2nd month

  • Active comparator
    2

    lansoprazole plus placebo for the first month, and lansoprazole plus mosapride for the second month

    Drug: placebo for the first and mosapride for the second month

Interventions

  • Drugmosapride for the first month and placebo for the 2nd month

    lansoprazole 30 mg once per day for 2 months mosapride 5 mg thrice per day, for the first month placebo thrice per day, for the second month

  • Drugplacebo for the first and mosapride for the second month

    lansoprazole 30 mg once per day for 2 months placebo thrice per day, for the first month mosapride 5 mg thrice per day, for the second month

06

What researchers measure

Primary outcomes

  1. Symptom improvement evaluated by frequent scale for the symptoms of gastroesophageal reflux disease (FSSG)

    Time frame: before enrollment, one month after treatment, two months after treatment

07

Study locations

1 site
  • Lotung Poh-Ai Hospital
    Lotung Town, Ilan County, 265, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00729339
Lead sponsor
Lotung Poh-Ai Hospital
Collaborators
Tomorrow Medical Foundation
First posted
Aug 7, 2008
Start date
Jun 2008
Primary completion
Apr 2009
Completion
May 2009
Last update
May 13, 2009

Study contacts

Hwai-Jeng Lin, M.D.
principal investigator · Lotung Poh-Ai Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.

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