A Phase 2 interventional study of Aolanti Weipang Tablets and Placebo in Functional Dyspepsia, sponsored by Jiangxi Qingfeng Pharmaceutical Co. Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-06-03.
Sponsored by Jiangxi Qingfeng Pharmaceutical Co. Ltd. · Phase 2, Interventional, and Treatment
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
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.
363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.
This study's planned enrollment of 236 is above the median of 87 across 297 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →Jiangxi Qingfeng Pharmaceutical Co. Ltd. is the lead sponsor of 32 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
3 tablets one time, 3 times a day(tid)
Drug: Aolanti Weipang Tablets
3 tablets one time, 3 times a day(tid)
Drug: Placebo
3 tablets one time, 3 times a day(tid)
3 tablets one time, 3 times a day(tid)
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.
Time frame: 4 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 postprandial discomfort and early satiation
Time frame: 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
Time frame: 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
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Jiangxi Qingfeng Pharmaceutical Co. Ltd.