NCT00272103

Brief Summary

This study aims to determine the efficacy and optimal dose of the prokinetic itopride for the treatment of patients with functional dyspepsia. The study will test in patients with functional dyspepsia the hypothesis that itopride is superior to placebo with regard to the improvement of symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2000

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2002

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2006

Completed
Last Updated

May 4, 2006

Status Verified

November 1, 2005

First QC Date

January 3, 2006

Last Update Submit

May 3, 2006

Conditions

Functional Dyspepsia

Keywords

functional dyspepsianon ulcer dyspepsiadrug treatment

Outcome Measures

Primary Outcomes (4)

  • After 8 weeks of treatment:

  • Change of the severity of functional dyspepsia symptoms assessed by the Leeds Dyspepsia Questionnaire)

  • Patient's global assessment of efficacy (proportion of patients symptom-free or markedly improved)

  • Improvement of pain and/or fullness by at least one grade on a 5-grade scale.

Secondary Outcomes (1)

  • Safety parameters

Interventions

Itopride (drug)DRUG

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of functional dyspepsia (Rome criteria) -

You may not qualify if:

  • structural or biochemical abnormalities explaining the symptoms, concomitant symptoms of gastroesophageal reflux disease or irritable bowel syndrome dominating the clinical picture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Essen

Essen, Hesse, 45122, Germany

Location

Related Publications (1)

  • Holtmann G, Talley NJ, Liebregts T, Adam B, Parow C. A placebo-controlled trial of itopride in functional dyspepsia. N Engl J Med. 2006 Feb 23;354(8):832-40. doi: 10.1056/NEJMoa052639.

    PMID: 16495395RESULT

MeSH Terms

Interventions

itopridePharmaceutical Preparations

Study Officials

  • Gerald J Holtmann, MD

    Royal Adelaide Hospital, University of Adelaide

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2006

First Posted

January 4, 2006

Study Start

December 1, 2000

Study Completion

January 1, 2002

Last Updated

May 4, 2006

Record last verified: 2005-11

Locations

DE(1)