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

This study has been completed.

First Received: February 28, 2006 Last Updated: January 12, 2009 History of Changes

Sponsored by:	Zeria Pharmaceutical
Information provided by:	Zeria Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00298194

Purpose

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

Type and severity of symptoms a standardized nutrient challenge
The gastric nutrient distribution and gastric emptying of a standardized nutrient challenge
The association of the above with the manifestations of symptoms and symptom pattern

Condition	Intervention	Phase
Dyspepsia	Drug: Z-338	Phase II

MedlinePlus related topics: Indigestion

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by Zeria Pharmaceutical:

Estimated Enrollment:	52
Study Start Date:	February 2006
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298194

Locations

Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000

Sponsors and Collaborators

Zeria Pharmaceutical

Investigators

Principal Investigator:

Gerald Holtmann, Professor

Royal Adelaide Hospital

More Information

No publications provided

Study ID Numbers:	99010205E
Study First Received:	February 28, 2006
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00298194 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Study placed in the following topic categories:

Signs and Symptoms
Signs and Symptoms, Digestive
Dyspepsia

Additional relevant MeSH terms:

Signs and Symptoms
Signs and Symptoms, Digestive
Dyspepsia

ClinicalTrials.gov processed this record on May 06, 2009