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

NCT03971383 | Unknown Phase 2

• 1 other identifier: QF-WKP-203
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

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

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  8 weeks

• The safety of Aolanti Weikang Tablets on patients

  8 weeks

Study Arms (2)

Aolanti Weipang Tablets

EXPERIMENTAL

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

Drug: Aolanti Weipang Tablets

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Aolanti Weipang Tablets DRUG

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

Aolanti Weipang Tablets

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Jiangxi Qingfeng Pharmaceutical Co. Ltd.: lead

Study Sites (1)

The Second People's Hospital of Fujian Province

Fuzhou, Fujian, China

Location

Study Officials

• Xiao Ke

  The Second People's Hospital of Fujian Province

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qinsheng Zhang

CONTACT

+86-18036618691; zhangqinsheng@sh-qingfeng.net

Lihua Qing

CONTACT

+86-17717385428; qinglihua@sh-qingfeng.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 3, 2019
• Study Start: June 10, 2019
• Primary Completion: October 31, 2020
• Study Completion: May 3, 2021
• Last Updated: June 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)