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NCT00298194 Clinical Trial

The Effects of Z-338 in Subjects With and Without Functional Dyspepsia

Dyspepsia Clinical Trial

Official title:
The Effects of Z-338 on the Symptomatic Response to a Nutrient Challenge and Gastric Nutrient Distribution and Emptying in Subjects With and Without Functional Dyspepsia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00298194
Other study ID # 99010205E
Secondary ID
Status Completed
Phase Phase 2
First received February 28, 2006
Last updated January 12, 2009
Start date February 2006

Study information
Verified date January 2009
Source Zeria Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial Summary

To assess in subjects with and without functional dyspepsia the effects of Z-338 on:

1. Type and severity of symptoms a standardized nutrient challenge

2. The gastric nutrient distribution and gastric emptying of a standardized nutrient challenge

3. The association of the above with the manifestations of symptoms and symptom pattern

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date
Est. primary completion date July 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. Subjects with functional dyspepsia Positive documented diagnosis of FD via RomeII criteria and three or more moderate symptoms of Gastrointestinal Score

2. Subjects with no history of functional dyspepsia Clinical assessment, physical examination and laboratory testing without evidence for relevant abnormality.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Z-338

Locations
Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia

Sponsors (1)
Lead Sponsor Collaborator
Zeria Pharmaceutical

Country where clinical trial is conducted

Australia, 

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