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

Primary Purpose

Functional Dyspepsia

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Aolanti Weipang Tablets
Placebo
Sponsored by
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The Second People's Hospital of Fujian Province

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aolanti Weipang Tablets

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
The response rate of patient's on the syndrome of early satiation
the response rate of patient's on the syndrome of early satiation
The safety of Aolanti Weikang Tablets on patients
Number and grade of treatment-related adverse events, all of theAE are assessed by NCI-CTCAE

Full Information

First Posted
May 30, 2019
Last Updated
May 30, 2019
Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03971383
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 10, 2019 (Anticipated)
Primary Completion Date
October 31, 2020 (Anticipated)
Study Completion Date
May 3, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
236 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aolanti Weipang Tablets
Arm Type
Experimental
Arm Description
3 tablets one time, 3 times a day(tid)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
3 tablets one time, 3 times a day(tid)
Intervention Type
Drug
Intervention Name(s)
Aolanti Weipang Tablets
Intervention Description
3 tablets one time, 3 times a day(tid)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
3 tablets one time, 3 times a day(tid)
Primary Outcome Measure Information:
Title
The response rate of patient's on the syndrome of postprandial discomfort
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
The response rate of patient's on the syndrome of postprandial discomfort and early satiation
Description
the response rate of patient's on the syndrome of postprandial discomfort and early satiation
Time Frame
8 weeks
Title
The response rate of patient's on the syndrome of early satiation
Description
the response rate of patient's on the syndrome of early satiation
Time Frame
8 weeks
Title
The safety of Aolanti Weikang Tablets on patients
Description
Number and grade of treatment-related adverse events, all of theAE are assessed by NCI-CTCAE
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qinsheng Zhang
Phone
+86-18036618691
Email
zhangqinsheng@sh-qingfeng.net
First Name & Middle Initial & Last Name or Official Title & Degree
Lihua Qing
Phone
+86-17717385428
Email
qinglihua@sh-qingfeng.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao Ke
Organizational Affiliation
The Second People's Hospital of Fujian Province
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second People's Hospital of Fujian Province
City
Fuzhou
State/Province
Fujian
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Yao
Phone
+86-13600803702
Email
yjyllbgs@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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