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出境医 / 临床实验 / Phase Ⅱc Sutdy of Aolanti Weikang Tablets in FD PDS Patients

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

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

Condition or disease Intervention/treatment Phase
Functional Dyspepsia Drug: Aolanti Weipang Tablets Drug: Placebo Phase 2

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 10, 2019
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : May 3, 2021
Arms and Interventions
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)
Outcome Measures
Primary Outcome Measures :
  1. The response rate of patient's on the syndrome of postprandial discomfort [ Time Frame: 4 weeks ]
    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 :
  1. The response rate of patient's on the syndrome of postprandial discomfort and early satiation [ Time Frame: 8 weeks ]
    the response rate of patient's on the syndrome of postprandial discomfort and early satiation

  2. The response rate of patient's on the syndrome of early satiation [ Time Frame: 8 weeks ]
    the response rate of patient's on the syndrome of early satiation

  3. The safety of Aolanti Weikang Tablets on patients [ Time Frame: 8 weeks ]
    Number and grade of treatment-related adverse events, all of theAE are assessed by NCI-CTCAE


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
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Contact: Qinsheng Zhang +86-18036618691 zhangqinsheng@sh-qingfeng.net
Contact: Lihua Qing +86-17717385428 qinglihua@sh-qingfeng.net

Locations
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China, Fujian
The Second People's Hospital of Fujian Province
Fuzhou, Fujian, China
Contact: Xin Yao    +86-13600803702    yjyllbgs@163.com   
Sponsors and Collaborators
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Xiao Ke The Second People's Hospital of Fujian Province
Tracking Information
First Submitted Date  ICMJE May 30, 2019
First Posted Date  ICMJE June 3, 2019
Last Update Posted Date June 3, 2019
Estimated Study Start Date  ICMJE June 10, 2019
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2019) 		The response rate of patient's on the syndrome of postprandial discomfort [ Time Frame: 4 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
  • The response rate of patient's on the syndrome of postprandial discomfort and early satiation [ Time Frame: 8 weeks ]
    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 [ Time Frame: 8 weeks ]
    the response rate of patient's on the syndrome of early satiation
  • The safety of Aolanti Weikang Tablets on patients [ Time Frame: 8 weeks ]
    Number and grade of treatment-related adverse events, all of theAE are assessed by NCI-CTCAE
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase Ⅱc Sutdy of Aolanti Weikang Tablets in FD PDS Patients
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Functional Dyspepsia
Intervention  ICMJE
  • Drug: Aolanti Weipang Tablets
    3 tablets one time, 3 times a day(tid)
  • Drug: Placebo
    3 tablets one time, 3 times a day(tid)
Study Arms  ICMJE
  • Experimental: Aolanti Weipang Tablets
    3 tablets one time, 3 times a day(tid)
    Intervention: Drug: Aolanti Weipang Tablets
  • Placebo Comparator: Placebo
    3 tablets one time, 3 times a day(tid)
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 30, 2019) 		236
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 3, 2021
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03971383
Other Study ID Numbers  ICMJE QF-WKP-203
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Study Sponsor  ICMJE Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xiao Ke The Second People's Hospital of Fujian Province
PRS Account Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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