Trial intelligence / Profile preview

Z-338 Phase 2b in Functional Dyspepsia

NCT00323817Phase 2

Key facts

Status
Completed
Start
Apr 2006
Primary completion
Apr 2009
Countries
1
Modality
Small Molecules
Conditions
functional dyspepsia (FD)
01

Overview

Phase 2, randomised, double-blind trial in functional dyspepsia (FD) comparing Z-338 with Placebo (2 arms). Primary endpoint: Global Subject Outcome Assessment at 12 months. Started Apr 2006; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Z-338

    Z-338 (Acotiamide) administered orally.

  • Placebo

    Placebo administered orally.

03

Who it enrols

Adult patients with Functional Dyspepsia defined by Rome II criteria, where postprandial fullness and/or early satiety are the most bothersome symptoms.

04

Endpoints

Primary

  • Global Subject Outcome Assessment

Secondary

  • Individual Symptom Score

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