NCT00110968

Brief Summary

Itopride is a compound already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms of functional dyspepsia. Patients suffering from this condition have difficulties digesting food. Patients feel full after eating, they have bloating and have stomach pain. The goal of this study is to see if Itopride helps to relieve the symptoms of functional dyspepsia on a long-term basis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2004

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

September 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

May 16, 2005

Last Update Submit

February 6, 2017

Conditions

Dyspepsia

Keywords

Abdominal Symptom reliefFullnessBloatingIndigestionFunctional dyspepsia

Outcome Measures

Primary Outcomes (1)

  • Long-term safety

Secondary Outcomes (1)

  • Long-term relief of symptoms

Interventions

Itopride hydrochlorideDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients must have completed the 8 week double-blind study ITOFD04-01
  • Female patients must not be pregnant (must have a negative serum pregnancy test)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Broeders B, Tack J, Talley NJ. Itopride in functional dyspepsia: open-label, 1-year treatment follow-up of two multicenter, randomized, double-blind, placebo-controlled trials. Therap Adv Gastroenterol. 2025 Feb 20;18:17562848251321123. doi: 10.1177/17562848251321123. eCollection 2025.

    PMID: 39989849DERIVED

MeSH Terms

Conditions

Dyspepsia

Interventions

itopride

Condition Hierarchy (Ancestors)

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

Study Officials

  • Nicholas Talley, MD, PhD

    Mayo Clinic, Rochester, Minn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 16, 2005

First Posted

May 17, 2005

Study Start

September 1, 2004

Primary Completion

July 1, 2006

Study Completion

September 1, 2006

Last Updated

February 8, 2017

Record last verified: 2017-02