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

Qingfeng Pharmaceutical

Status and phase: Unknown; Phase 2

Conditions: Functional Dyspepsia

Treatments: Drug: Aolanti Weipang Tablets; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03971383

QF-WKP-203

Details and patient eligibility

About

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

Full 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.

Enrollment: 236 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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236 participants in 2 patient groups, including a placebo group

Aolanti Weipang Tablets

Experimental group

Description:

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

Treatment:

Drug: Aolanti Weipang Tablets

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo