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

This study has been completed.

Sponsor:

Information provided by:

Zeria Pharmaceutical

ClinicalTrials.gov Identifier:

NCT00298194

First received: February 28, 2006

Last updated: January 12, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 28, 2006

Last Updated Date

January 12, 2009

Start Date ^ICMJE

February 2006

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00298194 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Dyspepsia

Intervention ^ICMJE

Drug: Z-338

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT Number ^ICMJE

NCT00298194

Other Study ID Numbers ^ICMJE

99010205E

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Zeria Pharmaceutical

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Gerald Holtmann, Professor

Royal Adelaide Hospital

Information Provided By

Zeria Pharmaceutical

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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