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

Functional Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03971383
• Other study ID #: QF-WKP-203
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 10, 2019
• Est. completion date: May 3, 2021

Study information

• Verified date: May 2019
• Source: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Contact: Qinsheng Zhang
• Phone: +86-18036618691
• Email: zhangqinsheng[@]sh-qingfeng.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 236
• Est. completion date: May 3, 2021
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with FD according to the ROME ? 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.

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia

Intervention

Drug:
• Aolanti Weipang Tablets
3 tablets one time, 3 times a day(tid)
• Placebo
3 tablets one time, 3 times a day(tid)

Locations

Country	Name	City	State
China	The Second People's Hospital of Fujian Province	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The response rate of patient's on the syndrome of postprandial discomfort	the response rate of patients on the syndrome of postprandial discomfort, patient's evaluation of symptomatic improvement by overall treatment efficacy is classified by 7 point Likert scale: Significantly improved Improved Slightly improved No change Slightly worse Worse Much worse And only the Improved and Significantly improved classified as responsed.	4 weeks
Secondary	The response rate of patient's on the syndrome of postprandial discomfort and early satiation	the response rate of patient's on the syndrome of postprandial discomfort and early satiation	8 weeks
Secondary	The response rate of patient's on the syndrome of early satiation	the response rate of patient's on the syndrome of early satiation	8 weeks
Secondary	The safety of Aolanti Weikang Tablets on patients	Number and grade of treatment-related adverse events, all of theAE are assessed by NCI-CTCAE	8 weeks