NCT03225248

Brief Summary

This study is a multi-center, randomized, active-controlled, double-blind, non-inferiority, phase III clinical trial evaluating efficacy and safety of once-daily mosapride (UI05MSP015CT) in patients with functional dyspepsia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
143

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_3

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

10 months

First QC Date

July 12, 2017

Last Update Submit

July 20, 2017

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

  • Change of symptom score of functional dyspepsia

    Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire.

    4weeks

Secondary Outcomes (3)

  • Change of symptom score of functional dyspepsia

    2weeks

  • General symptom improvement

    2weeks, 4weeks

  • NDI-K questionnaire

    4weeks

Study Arms (2)

UI05MSP015CT

EXPERIMENTAL

UI05MSP015CT and Placebo of Gasmotin

Drug: UI05MSP015CT

Gasmotin

ACTIVE COMPARATOR

Placebo of UI05MSP015CT and Gasmotin

Drug: Gasmotin

Interventions

UI05MSP015CTDRUG

UI05MSP015CT and Placebo of Gasmotin

UI05MSP015CT
GasmotinDRUG

Placebo of UI05MSP015CT and Gasmotin

Gasmotin

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>19 years
  • Diagnosis of functional dyspepsia meeting Rome III criteria
  • At least three moderate or severe symptoms included in the Symptom Score
  • No structural lesions of upper gastrointestinal tract

You may not qualify if:

  • History of dyspepsia unrelated to functional dyspepsia or diseases
  • History of gastrointestinal surgery
  • History of malignancy in the previous 5 years
  • Psychiatric disorders including major depressive disorder and anxiety
  • Liver cirrhosis or abnormal liver laboratory findings
  • Advanced chronic kidney disease
  • Uncontrolled hypertension
  • Uncontrolled diabetes
  • Pregnancy and lactation
  • Recent history of taking medication affecting the gastrointestinal system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

mosapride

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2017

First Posted

July 21, 2017

Study Start

November 5, 2014

Primary Completion

September 5, 2015

Study Completion

October 12, 2015

Last Updated

July 21, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share