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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00298194
First Posted: March 1, 2006
Last Update Posted: January 14, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Zeria Pharmaceutical
  Purpose

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

Condition Intervention Phase
Dyspepsia Drug: Z-338 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00298194     History of Changes
Other Study ID Numbers: 99010205E
First Submitted: February 28, 2006
First Posted: March 1, 2006
Last Update Posted: January 14, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms