Effects of Itopride on Gastric Motor and Sensory Functions in Healthy Volunteers

A Double-blind, Randomized, Placebo-controlled, Single Center, Parallel Group Study to Evaluate the Effects of Itopride (100 mg and 200 mg t.i.d.) on Gastric Motor and Sensory Functions in Healthy Volunteers

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. This is a randomized, parallel group, two dose double blind, placebo-controlled study evaluating the effects of itopride (100 mg and 200 mg three times daily) and placebo on gastric motor and sensory functions in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Placebo; Drug: Itopride 100 mg; Drug: Itopride 200 mg

Detailed Description

In order to compare the effects of two itopride doses (100 mg and 200 mg three times daily) and placebo on gastric emptying and small bowel transit, gastric accommodation, and postprandial symptoms in female and male healthy volunteers, the following methods, which have been extensively used and validated in the laboratory, will be used:

Scintigraphic gastric emptying of solids and small bowel transit; single photon emission computed tomography to measure gastric accommodation; and the nutrient drink test to measure maximum tolerated volume and postprandial symptoms.

Based on data acquired using the same methods in the laboratory, the sample size of 15 subjects per group provides 80% power to detect an effect size of 16% in the primary endpoint of the study, that is a change in gastric volume (postprandial - fasting). This magnitude of change is considered clinically relevant.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1.Non-pregnant, non-breastfeeding females 2.18 years of age or older 3.Body mass index between 20 and 32 kg/m2 4.No alarm indicators on clinical assessment (weight loss of more than 7 kg, bleeding, recent recurrent vomiting, progressive dysphagia).

5.No history suggestive of small bowel obstruction

Exclusion Criteria:

1. Patients who have any gastrointestinal symptoms. Do not fulfill the criteria for the irritable bowel syndrome or functional dyspepsia clinically
2. Patients with a clinical diagnosis of gastroparesis or an alternative underlying disease that could be responsible for disturbed gastric function e.g. diabetes, post-vagotomy, post-fundoplication
3. Abdominal surgery other than appendectomy, cholecystectomy, hysterectomy, caesarian section or tubal ligation
4. Positive symptoms on an abridged bowel disease questionnaire
5. Use of medications that may alter gastrointestinal motility including metoclopramide, domperidone, tegaserod; acetaminophen and ibuprofen will be allowed
6. Current use of medications which may interact with the study medications
7. Patients who have taken any investigational medications within the past 30 days
8. Over the counter medication (except multivitamins) within 7 days of the study
9. Chronic gastrointestinal illness or any systemic disease that could affect gastrointestinal motility for controls
10. Known intolerance or allergy to eggs, milk and Ensure
11. History of chronic diarrhea

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Itopride	Drug: Itopride 100 mg; 100 mg three times daily; Drug: Itopride 200 mg; 200 mg three times daily
OTHER: Placebo	Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Gastric emptying	one week

Secondary Outcome Measures

Outcome Measure	Time Frame
Small bowel transit	one week
Gastric accommodation	one week
Postprandial symptoms	one week

Collaborators and Investigators

• Sponsor: Forest Laboratories
• Investigators: Principal Investigator: Nicholas J. Talley, M.D., Ph.D., Mayo Clinic College of Medicine

Study record dates

Study Major Dates

• Study Start: August 1, 2005
• Primary Completion (ACTUAL): November 1, 2005
• Study Completion (ACTUAL): November 1, 2005

Study Registration Dates

• First Submitted: August 28, 2006
• First Submitted That Met QC Criteria: August 29, 2006
• First Posted (ESTIMATE): August 30, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2017
• Last Update Submitted That Met QC Criteria: February 7, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: ITODG04-02