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

Functional Dyspepsia Clinical Trial

Official title:

To Verify 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: NCT00761358
• Other study ID #: 99010301
• Status: Completed
• Phase: Phase 3
• First received: September 25, 2008
• Last updated: November 21, 2010
• Start date: September 2008
• Est. completion date: August 2010

Study information

• Verified date: November 2010
• Source: Zeria Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to verify the superior efficacy of Z-338 to placebo in subjects with Functional Dyspepsia, focusing on the assessment of subjective symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 820
• Est. completion date: August 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 64 Years

Eligibility

Inclusion Criteria:

• Subjects showing at least one of the 4 symptoms (upper abdominal pain, upper abdominal discomfort, epigastric pain, epigastric burning) for at least 6 months before obtaining informed consent

• Subjects showing two or more of the following symptoms: upper abdominal pain, upper abdominal discomfort, post-prandial fullness, upper abdominal bloating, early satiety, nausea, vomiting and/or excessive belching for at least 3 months (one of them should be post-prandial fullness or early satiation)

• Bothersome symptoms should be post-prandial fullness, upper abdominal bloating or early satiety at the time of obtaining informed consent

Exclusion Criteria:

• Subjects with structural disease that is likely to explain the symptom (e.g., GERD, erosion, ulcer, hiatal hernia, bleeding, malignancy or Barrett's esophagus) confirmed by upper endoscopy at the obtaining informed consent

• Subjects have heartburn in last 12 weeks before obtaining informed consent

• Subjects with irritable bowel disease (IBS)

• Subjects with diabetes mellitus requiring treatment

• Subjects with serious anxiety disorder

• Subjects with depression and/or sleep disorder

• Subjects with biliary tract disease and/or pancreatitis (including chronic pancreatitis)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia
• Gastritis

Intervention

Drug:
• Z-338
Oral
• Placebo
Oral

Locations

Country	Name	City	State
n/a

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 in treatment period		4 week	No
Primary	Elimination rate of post-prandial fullness, upper abdominal bloating and early satiety at last visit in treatment period		4 week	No
Secondary	Individual symptom score		Every week	No
Secondary	SF-NDI		At 0, 4 week and 4 week after treatment	No
Secondary	General Impression		Every week	No
Secondary	Laboratory tests		At 0, 4 week and 4 week after treatment	Yes
Secondary	Adverse Event		4 week treatment period and 4 week after treatment	Yes