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To Evaluate the Efficacy of Z-338 in Subjects With Functional Dyspepsia

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.
ClinicalTrials.gov Identifier: NCT00333372
Recruitment Status : Completed
First Posted : June 5, 2006
Last Update Posted : January 14, 2009
Sponsor:
Information provided by:
Zeria Pharmaceutical

Brief Summary:
To Evaluate the efficacy of Z-338 in subjects with Functional Dyspepsia, focusing on the assessment of subjective symptoms in order to further determine the optimal dosage and efficacy parameters for PhaseIII clinical trials.

Condition or disease Intervention/treatment Phase
Functional Dyspepsia Drug: Z-338 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: To Evaluate the Efficacy of Z-338 in Subjects With Functional Dyspepsia, Focusing on the Assessment of Subjective Symptoms
Study Start Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion
U.S. FDA Resources




Primary Outcome Measures :
  1. General impression at last visit

Secondary Outcome Measures :
  1. General impression at each week
  2. Individual symptom score


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postprandial fullness, upper abdominal bloating and/or early satiety should be at least moderate for 2 days or more at the 7 days at Visit 1
  • upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiety, nausea, vomit and belching should be at least moderate for at least 2 symptoms for 2 days or more at the 7 days at Visit 1

Exclusion Criteria:

  • subjects taht heartburn should be the most bothersome symptom
  • Subjects presenting with primary complaints relieved by stool movements (IBS)
  • Subjects with diabetes by treatment
  • Subjects taht heartburn should be more than moderate

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): NCT00333372


Locations
Japan
Tohoku University
Sendai, Japan
Sponsors and Collaborators
Zeria Pharmaceutical
Investigators
Study Director: Michio Hongo, Professor Tohoku University Hospital

ClinicalTrials.gov Identifier: NCT00333372     History of Changes
Other Study ID Numbers: 99010207
First Posted: June 5, 2006    Key Record Dates
Last Update Posted: January 14, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases