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

NCT00370110 | Completed Phase 1

• 1 other identifier: ITODG04-02
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Gastric emptying

  one week

Secondary Outcomes (3)

• Small bowel transit

  one week

• Gastric accommodation

  one week

• Postprandial symptoms

  one week

Study Arms (2)

Itopride

EXPERIMENTAL

Drug: Itopride 100 mg; Drug: Itopride 200 mg

Placebo

OTHER

Other: Placebo

Interventions

Itopride 100 mg DRUG

100 mg three times daily

Itopride

Placebo OTHER

Placebo

Itopride 200 mg DRUG

200 mg three times daily

Itopride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• No history suggestive of small bowel obstruction

You may not qualify if:

• Patients who have any gastrointestinal symptoms. Do not fulfill the criteria for the irritable bowel syndrome or functional dyspepsia clinically
• 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
• Abdominal surgery other than appendectomy, cholecystectomy, hysterectomy, caesarian section or tubal ligation
• Positive symptoms on an abridged bowel disease questionnaire
• Use of medications that may alter gastrointestinal motility including metoclopramide, domperidone, tegaserod; acetaminophen and ibuprofen will be allowed
• Current use of medications which may interact with the study medications
• Patients who have taken any investigational medications within the past 30 days
• Over the counter medication (except multivitamins) within 7 days of the study
• Chronic gastrointestinal illness or any systemic disease that could affect gastrointestinal motility for controls
• Known intolerance or allergy to eggs, milk and Ensure
• History of chronic diarrhea

Sponsors & Collaborators

• Forest Laboratories: lead

Study Sites (1)

Mayo Clinic College of Medicine

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

itopride

Study Officials

• Nicholas J. Talley, M.D., Ph.D.

  Mayo Clinic College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2006
• First Posted: August 30, 2006
• Study Start: August 1, 2005
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: February 9, 2017

Record last verified: 2017-02

Locations

US (1)