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

Healthy Volunteers Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00308399
• Other study ID #: 1099-05
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 27, 2006
• Last updated: March 22, 2011
• Start date: November 2005
• Est. completion date: June 2007

Study information

• Verified date: March 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Itopride

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Axcan Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-prandial post drug volume-fasting post drug volume (gastric accommodation).