NCT00323817

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
282

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2006

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, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

3 years

First QC Date

May 8, 2006

Last Update Submit

May 26, 2015

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

  • Global subject Outcome Assessment

    12 month

Secondary Outcomes (1)

  • Individual symptom

    12 month

Interventions

Z-338DRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leuven University

Leuven, Belgium

Location

MeSH Terms

Interventions

Z 338

Study Officials

  • Jan Tack, PhD, MD

    Universitaire Ziekenhuizen KU Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 8, 2006

First Posted

May 10, 2006

Study Start

April 1, 2006

Primary Completion

April 1, 2009

Study Completion

October 1, 2009

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

BE(1)