NCT03971383

Phase Ⅱc Sutdy of Aolanti Weikang Tablets in FD PDS Patients

A Multi-Center, Randomized, Double Blind, Placebo-controlled Phase Ⅱc Study of Aolanti Weipang Tablets in Patients With Postprandial Discomfort Syndrome of Functional Dyspepsia to Evaluate the Safety and Validity

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and validity of Aolanti Weipang Tablets in Patients with Postprandial Discomfort Syndrome of Functional Dyspepsia

Detailed description

This is a multi-center, randomized, double blind, placebo-controlled phase Ⅱc study to evaluate the safety and validity of Aolanti Weipang Tablets in patients with postprandial discomfort syndrome of Functional Dyspepsia(FD). This study will consecutive about 12 weeks, including 2 weeks of screening, 1 week of blank run-in, 1 week of placebo run-in, 4 weeks of double blind treatment and 4 weeks of observation after treatment. The subjects will be randomly given orally Aolanti Weikang Tablets or placebo tablets at a 1:1 ratio three times a day(tid) with 3 tablets one time for the treatment.

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
DRUG	Aolanti Weipang Tablets	3 tablets one time, 3 times a day(tid)
DRUG	Placebo	3 tablets one time, 3 times a day(tid)

Timeline

• Start date: 2019-06-10
• Primary completion: 2020-10-31
• Completion: 2021-05-03
• First posted: 2019-06-03
• Last updated: 2019-06-03

Locations

1 site across 1 country: China