NCT00308399

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2 healthy-volunteers

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

March 23, 2011

Status Verified

March 1, 2011

Enrollment Period

1.6 years

First QC Date

March 27, 2006

Last Update Submit

March 22, 2011

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Post-prandial post drug volume-fasting post drug volume (gastric accommodation).

Interventions

ItoprideDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

itopride

Study Officials

  • Nicholas J. Talley, M.D., Ph.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 27, 2006

First Posted

March 29, 2006

Study Start

November 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

March 23, 2011

Record last verified: 2011-03

Locations

US(1)