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

NCT ID: NCT00761358

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

PHASE3

Total Enrollment

820 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Functional Dyspepsia

Keywords

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Acotiamide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Z-338

Group Type EXPERIMENTAL

Z-338

Intervention Type DRUG

Oral

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral

Interventions

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Z-338

Oral

Intervention Type DRUG

Placebo

Oral

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 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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Michio Hongo, Professor

Role: STUDY_DIRECTOR

Tohoku University Hospital

Locations

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Hokkaido, , Japan

Site Status

Tokyo, , Japan

Site Status

Countries

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Japan

References

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Matsueda K, Hongo M, Tack J, Saito Y, Kato H. A placebo-controlled trial of acotiamide for meal-related symptoms of functional dyspepsia. Gut. 2012 Jun;61(6):821-8. doi: 10.1136/gutjnl-2011-301454. Epub 2011 Dec 9.

Reference Type DERIVED
PMID: 22157329 (View on PubMed)

Other Identifiers

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99010301

Identifier Type: -

Identifier Source: org_study_id