Functioanl Dyspepsia Clinical Trial
Official title:
The Effect of Z-338 in Subjects With Functional Dyspepsia, Evaluate the Function of Gastro-duodenum by Ultrasound
| 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 |
Z-338; PhaseIIb, Single-centre, Randomized, Double-blind, Placebo-controlled, Parallel group study in Subjects with Functional Dyspepsia, evaluate the motility of gastro-duodenum by ultrasound
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | July 2010 |
| Est. primary completion date | September 2009 |
| 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 that heartburn should be the most bothersome symptom - Subjects presenting with primary complaints relieved by stool movements (IBS) - Subjects with diabetes by treatment - Subjects that heartburn should be more than moderate |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Kawasaki Medical School | Kurashiki | Okayama |
| Lead Sponsor | Collaborator |
|---|---|
| Zeria Pharmaceutical |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Distal stomach square, Gastric emptying, Motility index, Duodenogastric reflux index |