To Evaluate the Efficacy and Safety in Subjects With Functional Dyspepsia

NCT ID: NCT00323817

Last Updated: 2015-05-28

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

282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-10-31

Brief Summary

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To evaluate the efficacy and safety of Z-338 in subjects with Functional Dyspepsia

Detailed Description

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Conditions

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Functional Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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Z-338

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects presenting diagnosis of FD as defined by the Rome II
* Subjects presenting postprandial fullness and/or Early satiety should be the most bothersome symptom

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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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Jan Tack, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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Leuven University

Leuven, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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99010206E

Identifier Type: -

Identifier Source: org_study_id

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