NCT00382577

Brief Summary

The purpose of this study is to evaluate the effects of itopride in patients with heartburn.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

September 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2006

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

First QC Date

September 27, 2006

Last Update Submit

February 7, 2017

Conditions

Heartburn

Outcome Measures

Primary Outcomes (1)

  • 24-hour pH Monitoring

    after 5 days of treatment

Interventions

ItoprideDRUG
PlaceboDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Otherwise healthy males and females aged 18-70, with at least 3 episodes of heartburn or acid regurgitation per week.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Heartburn

Interventions

itopride

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Philip, Jr. B. Miner, M.D.

    The Oklahoma Foundation for Digestive Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2006

First Posted

September 29, 2006

Study Start

October 1, 2006

Study Completion

December 1, 2006

Last Updated

February 9, 2017

Record last verified: 2017-02

Locations

US(1)