To Evaluate the Efficacy of Z-338 in Subjects With Functional Dyspepsia

Functional Dyspepsia Clinical Trial

Official title:

To Evaluate the Efficacy of Z-338 in Subjects With Functional Dyspepsia, Focusing on the Assessment of Subjective Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00333372
• Other study ID #: 99010207
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2006
• Last updated: January 12, 2009
• Start date: April 2006

Study information

• Verified date: January 2009
• Source: Zeria Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Gastritis

Intervention

Drug:
• Z-338

Locations

Country	Name	City	State
Japan	Tohoku University	Sendai

Sponsors (1)

Lead Sponsor	Collaborator
Zeria Pharmaceutical

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General impression at last visit
Secondary	General impression at each week
Secondary	Individual symptom score