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

This study has been completed.
Information provided by:
Zeria Pharmaceutical Identifier:
First received: February 28, 2006
Last updated: January 12, 2009
Last verified: January 2009

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)

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

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
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Please refer to this study by its identifier: NCT00298194

Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
Zeria Pharmaceutical
Principal Investigator: Gerald Holtmann, Professor Royal Adelaide Hospital
  More Information Identifier: NCT00298194     History of Changes
Other Study ID Numbers: 99010205E
Study First Received: February 28, 2006
Last Updated: January 12, 2009

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms processed this record on September 21, 2017