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

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

Study Overview

• Status: Unknown
• Conditions: Functional Dyspepsia
• Intervention / Treatment: Drug: Aolanti Weipang Tablets; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 236
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • The Second People's Hospital of Fujian Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Aolanti Weipang Tablets; 3 tablets one time, 3 times a day(tid)	Drug: Aolanti Weipang Tablets; 3 tablets one time, 3 times a day(tid)
PLACEBO_COMPARATOR: Placebo; 3 tablets one time, 3 times a day(tid)	Drug: Placebo; 3 tablets one time, 3 times a day(tid)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Investigators: Principal Investigator: Xiao Ke, The Second People's Hospital of Fujian Province

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 10, 2019
• Primary Completion (ANTICIPATED): October 31, 2020
• Study Completion (ANTICIPATED): May 3, 2021

Study Registration Dates

• First Submitted: May 30, 2019
• First Submitted That Met QC Criteria: May 30, 2019
• First Posted (ACTUAL): June 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 3, 2019
• Last Update Submitted That Met QC Criteria: May 30, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: QF-WKP-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No