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

NCT ID: NCT03971383

Last Updated: 2019-06-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-10
• Study Completion Date: 2021-05-03

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Aolanti Weipang Tablets

3 tablets one time, 3 times a day(tid)

Group Type: EXPERIMENTAL

Aolanti Weipang Tablets

Intervention Type: DRUG

3 tablets one time, 3 times a day(tid)

Placebo

3 tablets one time, 3 times a day(tid)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

3 tablets one time, 3 times a day(tid)

Interventions

Aolanti Weipang Tablets

3 tablets one time, 3 times a day(tid)

Intervention Type: DRUG

Placebo

3 tablets one time, 3 times a day(tid)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with FD according to the ROME Ⅳ criteria，and must with symptom of bothersome postprandial fullness;
• Patients diagnosed with Stagnation of Qi according to traditional Chinese medicine;
• At least the symptom of bothersome postprandial fullness ≥4 on the Visual Analogue Scale(VAS), and the number of recurrence day must ≥3 in one week;
• Provides voluntary informed consent after receiving adequate explanation and demonstrates thorough understanding of the nature of the study.

Exclusion Criteria

• The patients with high placebo effect, the scores in placebo run-in stage declined much than 30 percent of the mean VAS per week compare to blank run-in stage;
• Unable to take drugs orally;
• Within 7 days of Screening, the average number of stool > 2 times/day;
• Within 7 days of Screening, with the presence of ≥ type 5 stool form per the Bristol Stool Form Scale;
• History of drug or aurantium allergy;
• Patients with positive in fecal occult blood test;
• Abnormal liver and/or kidney function: creatinine >1.5*ULN (upper limits of normal), and/or AST and/or ALT > 2.0*ULN, and/or TBil > 1.5*ULN;
• Patients with family history of prolonged QT syndrome or have history of torsional apical ventricular tachycardia; or QTc > 480 ms;
• Digestive diseases, or other diseases within 6 months before Screening that may affect the swallow, absorption, or metabolism of study drugs, and not yet fully recovered judged by the Investigator;
• Patients who positive in H. Pylori test plan to accept the H. pylori eradication therapy within the trial;
• Serious complications (heart, brain, lung, liver, kidney, or blood disease);
• Neuropsychiatric disorders;
• Use of prohibited medications;
• Pregnant or lactating women or those who are planning to conceive during the study period;
• Drug abuse within 3 months, or alcohol abuse within 6 months;
• Patients participated in other clinical trials within 30 days before taking drugs;
• Other conditions deemed ineligible for enrollment by Investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiao Ke

Role: PRINCIPAL_INVESTIGATOR

The Second People's Hospital of Fujian Province

Locations

The Second People's Hospital of Fujian Province

Fuzhou, Fujian, China

Countries

China

Central Contacts

Qinsheng Zhang

Role: CONTACT

zhangqinsheng@sh-qingfeng.net

+86-18036618691

Lihua Qing

Role: CONTACT

qinglihua@sh-qingfeng.net

+86-17717385428

Facility Contacts

Xin Yao

Role: primary

yjyllbgs@163.com

+86-13600803702

Other Identifiers

QF-WKP-203

Identifier Type: -

Identifier Source: org_study_id