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

Zeria Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Functional Dyspepsia

Treatments: Drug: Z-338

Study type: Interventional

Funder types: Industry

Identifiers

NCT00333372

99010207

Details and patient eligibility

About

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.

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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind