Clinical trial NCT03971383: Phase Ⅱc Sutdy of Aolanti Weikang Tablets in FD PDS Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Functional Dyspepsia
Lead sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2019-06-03
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The response rate of patient's on the syndrome of postprandial discomfort
timeFrame: 4 weeks
Secondary outcomes:
measure: The response rate of patient's on the syndrome of postprandial discomfort and early satiation
timeFrame: 8 weeks
measure: The response rate of patient's on the syndrome of early satiation
timeFrame: 8 weeks
measure: The safety of Aolanti Weikang Tablets on patients
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The Second People's Hospital of Fujian Province
state: Fujian
Study officials:
affiliation: The Second People's Hospital of Fujian Province
name: Xiao Ke
role: PRINCIPAL_INVESTIGATOR
References: