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

November 21, 2010 updated by: Zeria Pharmaceutical

To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia, Focusing on the Assessment of Subjective Symptoms

The purpose of this study is to verify the superior efficacy of Z-338 to placebo in subjects with Functional Dyspepsia, focusing on the assessment of subjective symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

820

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hokkaido, Japan
      • Tokyo, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects showing at least one of the 4 symptoms (upper abdominal pain, upper abdominal discomfort, epigastric pain, epigastric burning) for at least 6 months before obtaining informed consent
  • Subjects showing two or more of the following symptoms: upper abdominal pain, upper abdominal discomfort, post-prandial fullness, upper abdominal bloating, early satiety, nausea, vomiting and/or excessive belching for at least 3 months (one of them should be post-prandial fullness or early satiation)
  • Bothersome symptoms should be post-prandial fullness, upper abdominal bloating or early satiety at the time of obtaining informed consent

Exclusion Criteria:

  • Subjects with structural disease that is likely to explain the symptom (e.g., GERD, erosion, ulcer, hiatal hernia, bleeding, malignancy or Barrett's esophagus) confirmed by upper endoscopy at the obtaining informed consent
  • Subjects have heartburn in last 12 weeks before obtaining informed consent
  • Subjects with irritable bowel disease (IBS)
  • Subjects with diabetes mellitus requiring treatment
  • Subjects with serious anxiety disorder
  • Subjects with depression and/or sleep disorder
  • Subjects with biliary tract disease and/or pancreatitis (including chronic pancreatitis)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: Placebo
Oral
Experimental: Z-338
Drug: Z-338
Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
General impression at last visit in treatment period
Time Frame: 4 week
4 week
Elimination rate of post-prandial fullness, upper abdominal bloating and early satiety at last visit in treatment period
Time Frame: 4 week
4 week

Secondary Outcome Measures

Outcome Measure
Time Frame
Individual symptom score
Time Frame: Every week
Every week
SF-NDI
Time Frame: At 0, 4 week and 4 week after treatment
At 0, 4 week and 4 week after treatment
General Impression
Time Frame: Every week
Every week
Laboratory tests
Time Frame: At 0, 4 week and 4 week after treatment
At 0, 4 week and 4 week after treatment
Adverse Event
Time Frame: 4 week treatment period and 4 week after treatment
4 week treatment period and 4 week after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zeria Pharmaceutical

Investigators

  • Study Director: Michio Hongo, Professor, Tohoku University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

September 25, 2008

First Submitted That Met QC Criteria

September 25, 2008

First Posted (Estimate)

September 29, 2008

Study Record Updates

Last Update Posted (Estimate)

November 23, 2010

Last Update Submitted That Met QC Criteria

November 21, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99010301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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