The Effect of Z-338 in Subjects With Functional Dyspepsia

Zeria Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Functioanl Dyspepsia

Treatments: Drug: Z-338

Study type: Interventional

Funder types: Industry

Identifiers

NCT00458328

99010208

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind