NCT00458328

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2007

Typical duration 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, 2007

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 10, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

November 23, 2010

Status Verified

November 1, 2010

Enrollment Period

2.4 years

First QC Date

April 9, 2007

Last Update Submit

November 21, 2010

Conditions

Functioanl Dyspepsia

Outcome Measures

Primary Outcomes (1)

  • Distal stomach square, Gastric emptying, Motility index, Duodenogastric reflux index

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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kawasaki Medical School

Kurashiki, Okayama-ken, 701-0192, Japan

Location

MeSH Terms

Interventions

Z 338

Study Officials

  • Ken Haruma, MD, PhD

    Kawasaki Medical School

    STUDY CHAIR

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

April 9, 2007

First Posted

April 10, 2007

Study Start

April 1, 2007

Primary Completion

September 1, 2009

Study Completion

July 1, 2010

Last Updated

November 23, 2010

Record last verified: 2010-11

Locations

JP(1)