Post-Marketing Surveillance of the Tanreqing Injection: a Real World Study

Adverse Drug Reaction Clinical Trial

Official title:

Post-Marketing Surveillance of the Tanreqing Injection: a Real World Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02094638
• Other study ID #: PekingUTH-Pharmacy-003
• Status: Completed
• Phase: N/A
• First received: March 20, 2014
• Last updated: February 18, 2016
• Start date: January 2014

Study information

• Verified date: February 2016
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Tanreqing Injection is widely used in respiratory disease with Chinese medicine syndrome of retention of phlegm and heat in Fei. This study record clinical use of Tanreqing Injection in the real world, observe the adverse drug reactions/ adverse drug events during treatment, and figure out why Tanreqing induced severe allergic reaction happens.

Description:

As a compound traditional Chinese medicine, Tanreqing Injection was approved by China Food and Drug Administration(CFDA) in 2003, and widely used respiratory disease, such as biofilm related upper respiratory infections, pneumonia and bronchitis. During its 11 years marketing in China, there was hardly any serious adverse drug reactions except for a few cases reported as severe allergic reaction. In this study, clinical pharmacists in selected hospitals will not only record the clinical use and the adverse drug reactions/ adverse drug events of this injection, but also try to figure out why drug-induced severe allergic reaction happens through a nested case-control study. This real world study for Tanreqing Injection with 30400 patients will be conducted from January.2014 to June.2016.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30400
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Months and older

Eligibility

Inclusion Criteria:

• Patients who use the Tanreqing Injection in selected hospitals in China, including inpatient and outpatient.

• Outpatients will be only in some hospitals which can get the patients' complete information.

Exclusion Criteria:

• Patients who are less than 24 months.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Adverse Drug Reaction
• Drug Allergy
• Drug-Related Side Effects and Adverse Reactions

Locations

Country	Name	City	State
China	People's Hospital of Rongcheng	Baoding	Hebei
China	The Third Affiliated Hospital of Inner Mongolia Medical College	Baotou	Inner Mongolia
China	Beijing Geriatric Hospital	Beijing	Beijing
China	Beijing Luhe Hospital, Capital Medical University	Beijing	Beijing
China	Peking university third hospital	Beijing
China	The 263rd Hospital of Chinese People's Liberation Army	Beijing	Beijing
China	The Fengtai district Hospital of Integrated TCM & WM	Beijing	Beijing
China	Bijie First Municipal People's Hospital	Bijie	Guizhou
China	People's Hospital of Cangzhou	Cangzhou	Hebei
China	The First Hospital of Jilin University	Changchun	Jilin
China	The Second Hospital of Jilin University	Changchun	Jilin
China	The Fourth Hospital of Changsha	Changsha	Hunan
China	the Second Xiangya Hospital of Central South University	Changsha	Hunan
China	ShuangLiu Hospital of Traditional Chinese Medical	Chengdu	Sichuan
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	The Third People's Hospital of Chengdu	Chengdu	Sichuan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Chongqing Jiulongpo First People's Hospital	Chongqing	Chongqing
China	Chongqing Kaixian County People's Hospital	Chongqing	Chongqing
China	Chongqing Three Gorges Central Hospital	Chongqing	Chongqing
China	Chongqing Traditional Chinese Medicine Hospital	Chongqing	Chongqing
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The Third People's Hospital of Chongqing	Chongqing	Chongqing
China	Traditional Chinese Medical Hospital of Bai Autonomous Prefecture of Dali	Dali	Yunnan
China	Fifth Hospital of Datong	Datong	Shanxi
China	DuJiangyan Traditional Chinese Medicine Hospital	Dujiangyan	Sichuan
China	Fenyang Hospital of Shanxi Province	Fenyang	Shanxi
China	Guiyang Children's Hospital	Guiyang	Guizhou
China	Guiyang Pulmonary Hospital	Guiyang	Guizhou
China	Guizhou Cancer Hospital	Guiyang	Guizhou
China	The 44th Hospital of chinese People's Liberation Army	Guiyang	Guizhou
China	The Affiliated Hospital of Hainan medical College	Haikou	Hainan
China	First Hospital of Handan City	Handan	Hebei
China	Zhejiang Provincial Hospital of TCM	Hangzhou	Zhejiang
China	Anhui Provincial Children's Hospital	Hefei	Anhui
China	Hejian Municipal People's Hospital	Hejian	Hebei
China	The First Hospital Of Huhhot	Huhehaote	Inner Mongolia
China	The fourth Hospital of Inner Mongolia	Huhehaote	Inner Mongolia
China	The Third People's Hospital of Huizhou	Huizhou	Guangdong
China	Affiliated Hospital of Shandong University of Traditional Chinese Medicine	Jinan	Shandong
China	Shandong Cancer Hospital	Jinan	Shandong
China	The Second People's Hospital of Jinzhong	Jinzhong	Shanxi
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Second Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Gansu Provincial Hospital of Traditional Chinese Medicine	Lanzhou	Gansu
China	Lanzhou Petrochemical General Hospital	Lanzhou	Gansu
China	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	The First Hospital of Nanchang	Nanchang	Jiangxi
China	The Second Hospital of Nanchang	Nanchang	Jiangxi
China	Traditional Chinese Medical Hospital of Jiangxi Province	Nanchang	Jiangxi
China	People's Hospital of Nanbu County	Nanchong	Sichuan
China	Jiangning District Hospital of Traditional Chinese Medicine	Nanjing	Jiangsu
China	Ningbo First Hospital	Ningbo	Zhejiang
China	The 152nd Hospital of chinese People's Liberation Army	Pingdingshan	Henan
China	The First Hospital of Qinhuangdao	Qinhuangdao	Hebei
China	Shanghai Changzheng Hospital	Shanghai	Shanghai
China	Shanghai First People's Hospital Branch	Shanghai	Shanghai
China	Shanghai Minhang District Central Hospital	Shanghai	Shanghai
China	Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine	Shanghai	Shanghai
China	Wu Song Central Hospital of Shanghai	Shanghai	Shanghai
China	Shenyang 242 Hospital	Shenyang	Liaoning
China	The Third People's Hospital of Shenzhen	Shenzhen	Guangdong
China	Bethune International Peace Hospital of the Chinese PLA	Shijiazhuang	Hebei
China	Hebei Zhaoxian People's Hospital	Shijiazhuang	Hebei
China	the Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	The Center Hospital of Shuozhou	Shuozhou	Shanxi
China	Maternal and Child Health Care Hospital of Taiyuan	Taiyuan	Shanxi
China	Shanxi Maternity and Children Health Hospital	Taiyuan	Shanxi
China	The 254th Hospital of chinese People's Liberation Army	Tianjin	Tianjin
China	The 464th Hospital of chinese People's Liberation Army	Tianjin	Tianjin
China	The Second Affiliated Hospital of Wenzhou Medical College	Wenzhou	Zhejiang
China	Wenzhou Central Hospital	Wenzhou	Zhejiang
China	Wenzhou Yueqing People's Hospital	Wenzhou	Zhejiang
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Hubei Xinhua Hospital	Wuhan	Hubei
China	Hubei Zhongshan Hospital Affiliated to Wuhan University	Wuhan	Hubei
China	The Second Hospital of Wulanchabu City	Wulanchabu	Inner Mongolia
China	People's Hospital of Xinjiang Uigur Autonomous Region	Wulumuqi	Xinjiang
China	Qinghai Women and Childhood Hospital	Xining	Qinghai
China	Xinle Municipal Hospital of Hebei	Xinle	Hebei
China	Xintai People's Hospital	Xintai	Shandong
China	The First People's Hospital of Yangzhou City	Yangzhou	Jiangsu
China	Yantai Municipal Laiyang Central Hospital	Yantai	Shandong
China	Chinese Traditional Medicine Hospital of Ningxia Autonomous Region	Yinchuan	Ningxia
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	The First People's Hospital of Yinchuan	Yinchuan	Ningxia
China	Henan Province Hospital of TCM	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Zhongshan Municipal People's Hospital	Zhongshan	Guangdong
China	Affiliated Hospital of Zunyi Medical College	Zunyi	Guizhou

Sponsors (92)

Lead Sponsor

Collaborator

Suodi ZHAI

Anhui Provincial Children's Hospital, Beijing Geriatric Hospital, Beijing Luhe Hospital, Capital Medical University, Bethune International Peace Hospital of the Chinese PLA, Bijie First Municipal People's Hospital, Cancer Hospital of Guizhou Province, Central South University, Chongqing Jiulongpo First People's Hospital, Chongqing Kaixian County People's Hospital, Chongqing Three Gorges Central Hospital, Chongqing Traditional Chinese Medicine Hospital, DuJiangyan Traditional Chinese Medicine Hospital, Fengtai district Hospital of Chinese and Western medicine, Beijing, Fenyang Hospital of Shanxi Province, First Hospital of Handan City, First Hospital of Jilin University, Gansu Provincial Hospital, General Hospital of Ningxia Medical University, Guiyang Children's Hospital, Guiyang Pulmonary Hospital, Hebei Zhaoxian People's Hospital, Hejian Municipal People's Hospital, Henan Province Hospital of TCM, Hubei Cancer Hospital, Hubei Xinhua Hospital, Hubei Zhongshan Hospital Affiliated to Wuhan University, Jiangning District Hospital of Traditional Chinese Medicine, Jiangxi Provincial People's Hopital, Lanzhou Petrochemical General Hospital, Maternal and Child Health Care Hospital of Taiyuan, Ningbo First Hospital, Peking University, People's Hospital of Cangzhou, People's Hospital of Nanbu County, People's Hospital of Rongcheng, People's Hospital of Xinjiang Uigur Autonomous Region, Qinghai Women and Childhood Hospital, Second Affiliated Hospital of Guangzhou Medical University, Second Affiliated Hospital of Wenzhou Medical University, Second Hospital of Jilin University, Shandong Cancer Hospital, Shandong University of Traditional Chinese Medicine, Shanghai Changzheng Hospital, Shanghai First People's Hospital Branch, Shanghai Kaibao Pharmaceutical CO.,LTD., Shanghai Minhang District Central Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanxi Maternity and Children Health Hospital, Shenyang 242 Hospital, Shenzhen Third People's Hospital, ShuangLiu Hospital of Traditional Chinese Medical, Sichuan Provincial People's Hospital, The 152nd Hospital of chinese People's Liberation Army, The 254th Hospital of chinese People's Liberation Army, The 263rd Hospital of Chinese People's Liberation Army, The 44th Hospital of chinese People's Liberation Army, The 464th Hospital of chinese People's Liberation Army, The Affiliated Hospital of Hainan medical College, The Center Hospital of Shuozhou, The Chengdu Third People's Hospital, The Fifth People's Hospital of Datong, The First Affiliated Hospital of Kunming Medical College, The First Affiliated Hospital of Zhengzhou University, The First Hospital Of Huhhot, The First Hospital of Nanchang, The First Hospital of Qinhuangdao, The First People's Hospital of Yangzhou City, The First People's Hospital of Yinchuan, The Fourth Hospital of Changsha, The fourth Hospital of Inner Mongolia, The Second Affiliated Hospital of Chongqing Medical University, The Second Affiliated Hospital of Kunming Medical University, The Second Hospital of Hebei Medical University, The Second Hospital of Nanchang, The Second Hospital of Wulanchabu City, The Second People's Hospital of Jinzhong, The Third Affiliated Hospital of Inner Mongolia Medical College, The Third People's Hospital of Chongqing, Traditional Chinese Medical Hospital of Bai Autonomous Prefecture of Dali, Traditional Chinese Medical Hospital of Jiangxi Province, Traditional Chinese Medicine Hospital of the Ningxia Hui Autonomous Region, Wenzhou Yueqing People's Hospital, West China Hospital, Wu Song Central Hospital of Shanghai, Xinle Municipal Hospital of Hebei, Xintai People's Hospital, Yantai Municipal Laiyang Central Hospital, Yunnan Provinical Hospital of Traditional Chinese Medicine, Zhejiang Provincial Hospital of TCM, Zhongshan People's Hospital, Guangdong, China, Zunyi Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Related Risk Factors in severe allergic reaction of Tanreqing Injection		30 months	Yes
Primary	Incidence of adverse drug reaction of Tanreqing Injection		30 months	Yes
Secondary	Outcomes of the patients who experienced an adverse drug reaction of Tanreqing Injection	Outcomes including cure, improved, null, or death.	30 months	Yes
Secondary	Administration of Tanreqing Injection in real world		30 months	Yes
Secondary	Population characteristics of the adverse drug reaction of Tanreqing Injection		30 months	Yes
Secondary	Off-lable use of Tanreqing Injection		30 months	Yes
Secondary	Drug combination of Tanreqing Injection in real world		30 months	Yes