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

This study has been completed.
Sponsor:
Information provided by:
Axcan Pharma
ClinicalTrials.gov Identifier:
NCT00370110
First received: August 28, 2006
Last updated: March 18, 2008
Last verified: March 2008
History of Changes
  Purpose

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. Do 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 tid) and placebo on gastric motor and sensory functions in healthy volunteers.


Condition Intervention Phase
Healthy
 Drug: Itopride Hydrochloride (prokinetic)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 Axcan Pharma:

Primary Outcome Measures:
  • Gastric emptying [ Time Frame: one week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Small bowel transit [ Time Frame: one week ] [ Designated as safety issue: No ]
  • Gastric accommodation [ Time Frame: one week ] [ Designated as safety issue: No ]
  • Postprandial symptoms [ Time Frame: one week ] [ Designated as safety issue: No ]

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)
Detailed Description:

In order to compare the effects of two itopride doses (100 mg and 200 mg tid) 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 7kg, 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00370110

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

No publications provided

Responsible Party: Dr. N. Talley, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00370110     History of Changes
Other Study ID Numbers: ITODG04-02
Study First Received: August 28, 2006
Last Updated: March 18, 2008
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 21, 2013