NCT00333372

Brief Summary

To Evaluate the efficacy of Z-338 in subjects with Functional Dyspepsia, focusing on the assessment of subjective symptoms in order to further determine the optimal dosage and efficacy parameters for PhaseIII clinical trials.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2006

Completed
Last Updated

January 14, 2009

Status Verified

January 1, 2009

First QC Date

June 2, 2006

Last Update Submit

January 12, 2009

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

  • General impression at last visit

Secondary Outcomes (2)

  • General impression at each week

  • Individual symptom score

Interventions

Z-338DRUG

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • subjects taht heartburn should be the most bothersome symptom
  • Subjects presenting with primary complaints relieved by stool movements (IBS)
  • Subjects with diabetes by treatment
  • Subjects taht heartburn should be more than moderate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tohoku University

Sendai, Japan

Location

MeSH Terms

Interventions

Z 338

Study Officials

  • Michio Hongo, Professor

    Tohoku University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 2, 2006

First Posted

June 5, 2006

Study Start

April 1, 2006

Last Updated

January 14, 2009

Record last verified: 2009-01

Locations

JP(1)