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

This study has been completed.
Information provided by (Responsible Party):
Forest Laboratories Identifier:
First received: August 28, 2006
Last updated: February 7, 2017
Last verified: February 2017
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.

Condition Intervention Phase
Drug: Itopride 100 mg
Other: Placebo
Drug: Itopride 200 mg
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Gastric emptying [ Time Frame: one week ]

Secondary Outcome Measures:
  • Small bowel transit [ Time Frame: one week ]
  • Gastric accommodation [ Time Frame: one week ]
  • Postprandial symptoms [ Time Frame: one week ]

Enrollment: 45
Study Start Date: August 2005
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Itopride Drug: Itopride 100 mg
100 mg three times daily
Drug: Itopride 200 mg
200 mg three times daily
Placebo Other: Placebo

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00370110

United States, Minnesota
Mayo Clinic College of Medicine
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Forest Laboratories
Principal Investigator: Nicholas J. Talley, M.D., Ph.D. Mayo Clinic College of Medicine
  More Information

Responsible Party: Forest Laboratories Identifier: NCT00370110     History of Changes
Other Study ID Numbers: ITODG04-02
Study First Received: August 28, 2006
Last Updated: February 7, 2017 processed this record on April 21, 2017