NCT00370084

Brief Summary

Itopride is a new compound that is already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms associated with gastroparesis. Due to inadequate gastric emptying, these patients often have symptoms of bloating, nausea and vomiting following ingestion of a meal. The goal of this study is to evaluate the effects of Itopride on gastric motor function and glycemia in patients with diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2005

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

March 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2006

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

1.2 years

First QC Date

August 28, 2006

Last Update Submit

February 7, 2017

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (1)

  • Gastric emptying assessment

    weekly

Secondary Outcomes (1)

  • Glycemia, relief of upper gastrointestinal symptoms, intragastric meal distribution

    weekly

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Other: Placebo

Itopride

EXPERIMENTAL
Drug: Itopride

Interventions

ItoprideDRUG

oral, three times daily

Itopride
PlaceboOTHER

oral, three times daily

Placebo

Eligibility Criteria

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

You may qualify if:

  • Type-1 and Type-2 diabetic patients
  • to 65 years old
  • Glycated haemoglobin level (HbA1c) below 9%
  • Body mass index (BMI) between 18 and 35 kg/m2

You may not qualify if:

  • Use of medications potentially influencing upper gastrointestinal motility or appetite within one week of the study (e.g. prokinetic drugs, macrolide antibiotics)
  • Exposure to radiation for research purposes during the previous 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Adelaide, Department of Medicine

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Gastroparesis

Interventions

itopride

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Horowitz, M.D.

    Royal Adelaide Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2006

First Posted

August 30, 2006

Study Start

March 1, 2005

Primary Completion

May 1, 2006

Study Completion

July 1, 2006

Last Updated

February 9, 2017

Record last verified: 2017-02

Locations

AU(1)