A Study to Evaluate the Effect of a Medicine on Gastric Functions in Healthy Volunteers.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00308399
Recruitment Status : Completed
First Posted : March 29, 2006
Last Update Posted : March 23, 2011
Axcan Pharma
Information provided by:
Mayo Clinic

Brief Summary:
A 7 day study which involves 2 nutrient drink tests, an ECG, a Scintigraphy scan, and a Sect scan. This study requires the participant to make 4 visits to the GCRC in the Charlton building but no overnight stays.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Itopride Phase 2 Phase 3

Detailed Description:

A screening interview and symptoms assessment by the Bowel Disease Questionnaire (BDQ) and consent will be obtained prior to the studies at the testing facility (General Clinical Research Center, 7th floor, Charlton Building, Mayo Clinic). Smoking status will be recorded. Vitals and an electrocardiogram will be obtained. Following an initial screening, subjects will be randomized to itopride or identical placebo.

Day 1: The participant will report in a fasting condition (10 hours) to the study center early in the morning. All participants will undergo the nutrient drink test to assess maximum tolerated volume and postprandial symptoms PRIOR to ingesting any medication.

Day 2-7: The patients will take the study medication as prescribed that is a tablet 30 minutes before meals, three times per day. On days 6, 7 and 8, the morning and midday dose of the medication intake will occur in the clinical research center under supervision of the study staff.

Day 6: The participant will return fasting for 10 hours to the study center early in the morning. Scintigraphic gastric and small bowel transit measurement will be performed, with medication ingested at standard times (30 min prior to meal), and the 99mTc-sulfur colloid labeled egg meal ingested 30 minutes after the morning dose of study medication. Imaging will be taken for 6 hours. Vitals and an electrocardiogram will be obtained Day 7: All participants will undergo a repeat nutrient drink test to assess postprandial symptoms at maximal satiety and 30 minutes after drug ingestion. The satiety study will be completed once a maximum tolerated volume is achieved, and the 30 minute post-meal questionnaire will be completed.

Day 8: The participant will return fasting to the study center early in the morning. Participants will undergo SPECT imaging to evaluate fasting gastric volume starting 30 minutes after ingestion of study medication. The participant will then ingest 300 ml of the nutrient drink Ensure", and postprandial gastric volumes will be calculated as described previously (41-46). Vitals will be obtained.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : November 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Primary Outcome Measures :
  1. Post-prandial post drug volume-fasting post drug volume (gastric accommodation).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
  1. Non-pregnant, non-breastfeeding females;
  2. 18- 45 years old
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00308399

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Axcan Pharma
Principal Investigator: Nicholas J. Talley, M.D., Ph.D. Mayo Clinic Identifier: NCT00308399     History of Changes
Other Study ID Numbers: 1099-05
First Posted: March 29, 2006    Key Record Dates
Last Update Posted: March 23, 2011
Last Verified: March 2011