The Effects of Z-338 in Subjects With and Without Functional Dyspepsia

NCT ID: NCT00298194

Last Updated: 2009-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28

Brief Summary

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

1. Type and severity of symptoms a standardized nutrient challenge

2. The gastric nutrient distribution and gastric emptying of a standardized nutrient challenge

3. The association of the above with the manifestations of symptoms and symptom pattern

Conditions

Dyspepsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Interventions

Z-338

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Subjects with functional dyspepsia Positive documented diagnosis of FD via RomeII criteria and three or more moderate symptoms of Gastrointestinal Score

2. Subjects with no history of functional dyspepsia Clinical assessment, physical examination and laboratory testing without evidence for relevant abnormality.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zeria Pharmaceutical

INDUSTRY

Sponsor Role: lead

Principal Investigators

Gerald Holtmann, Professor

Role: PRINCIPAL_INVESTIGATOR

Royal Adelaide Hospital

Locations

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Countries

Australia

Other Identifiers

99010205E

Identifier Type: -

Identifier Source: org_study_id