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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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Indigestion
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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

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

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

ClinicalTrials.gov processed this record on May 16, 2013