NCT00761358CompletedPhase 3
To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia, Focusing on the Assessment of Subjective Symptoms
Zeria Pharmaceutical0 sites820 target enrollmentStarted: September 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 820
- Primary Endpoint
- General impression at last visit in treatment period
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Z-338
Experimental
Intervention: Z-338 (Drug)
placebo
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
General impression at last visit in treatment period
Time Frame: 4 week
Elimination rate of post-prandial fullness, upper abdominal bloating and early satiety at last visit in treatment period
Time Frame: 4 week
Secondary Outcomes
- Individual symptom score(Every week)
- SF-NDI(At 0, 4 week and 4 week after treatment)
- General Impression(Every week)
- Laboratory tests(At 0, 4 week and 4 week after treatment)
- Adverse Event(4 week treatment period and 4 week after treatment)
Investigators
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