NCT00298194

Brief Summary

To assess in subjects with and without functional dyspepsia the effects of Z-338 on:

  1. 1.Type and severity of symptoms a standardized nutrient challenge
  2. 2.The gastric nutrient distribution and gastric emptying of a standardized nutrient challenge
  3. 3.The association of the above with the manifestations of symptoms and symptom pattern

Trial Health

80
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 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

February 1, 2006

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Last Updated

January 14, 2009

Status Verified

January 1, 2009

Enrollment Period

2.4 years

First QC Date

February 28, 2006

Last Update Submit

January 12, 2009

Conditions

Dyspepsia

Interventions

Z-338DRUG

Eligibility Criteria

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

You may qualify if:

  • Subjects with functional dyspepsia Positive documented diagnosis of FD via RomeII criteria and three or more moderate symptoms of Gastrointestinal Score
  • Subjects with no history of functional dyspepsia Clinical assessment, physical examination and laboratory testing without evidence for relevant abnormality.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Dyspepsia

Interventions

Z 338

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gerald Holtmann, Professor

    Royal Adelaide Hospital

    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
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 28, 2006

First Posted

March 1, 2006

Study Start

February 1, 2006

Primary Completion

July 1, 2008

Last Updated

January 14, 2009

Record last verified: 2009-01

Locations

AU(1)