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The Effect of Z-338 in Subjects With Functional Dyspepsia

NCT ID: NCT00458328

Last Updated: 2010-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2010-07-31

Brief Summary

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Z-338; PhaseIIb, Single-centre, Randomized, Double-blind, Placebo-controlled, Parallel group study in Subjects with Functional Dyspepsia, evaluate the motility of gastro-duodenum by ultrasound

Detailed Description

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Conditions

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Functioanl Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Z-338

Intervention Type DRUG

Eligibility Criteria

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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 that heartburn should be the most bothersome symptom
* Subjects presenting with primary complaints relieved by stool movements (IBS)
* Subjects with diabetes by treatment
* Subjects that heartburn should be more than moderate
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zeria Pharmaceutical

INDUSTRY

Sponsor Role lead

Principal Investigators

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Ken Haruma, MD, PhD

Role: STUDY_CHAIR

Kawasaki Medical School

Locations

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Kawasaki Medical School

Kurashiki, Okayama-ken, Japan

Site Status

Countries

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Japan

Other Identifiers

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99010208

Identifier Type: -

Identifier Source: org_study_id