Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP)
This study has been completed.
Sponsor:
TaiGen Biotechnology Co., Ltd.
Information provided by (Responsible Party):
TaiGen Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01537250
First received: February 5, 2012
Last updated: February 16, 2012
Last verified: February 2012
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Purpose
The purpose of this study is to evaluate the safety, tolerability and population pharmacokinetics of oral nemonoxacin in community-acquired pneumonia (CAP) subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Community-acquired Pneumonia |
Drug: Levofloxacin 500 mg placebol Drug: Nemonoxacin 3 tablets |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multi-center, Randomized, Double-blind, Double-dummy Parallel-controlled Phase II Clinical Study to Assess the Efficacy and Safety of Nemonoxacin Malate in Treating Adult Patients With Community-acquired Pneumonia (CAP) |
Resource links provided by NLM:
Further study details as provided by TaiGen Biotechnology Co., Ltd.:
Primary Outcome Measures:
- Per subject clinical cure rate [ Time Frame: 16days ] [ Designated as safety issue: Yes ]
- Per subject microbiological cure rate [ Time Frame: 16days ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetic profile of nemonoxacin in CAP subjects [ Time Frame: 3days ] [ Designated as safety issue: No ]
| Enrollment: | 192 |
| Study Start Date: | August 2009 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Nemonoxacin 750 mg
Nemonoxacin 750 mg 2 tablets.
|
Drug: Levofloxacin 500 mg placebol
oral form,,once adily,7~10 days
|
|
Active Comparator: Nemonoxacin 500 mg
Nemonoxacin 500 mg 3 tablets
|
Drug: Levofloxacin 500 mg placebol
oral form,,once adily,7~10 days
|
|
Active Comparator: Levofloxacin 500 mg
Levofloxacin 500 mg
|
Drug: Nemonoxacin 3 tablets
oral form,once daily,7~10 days
|
Detailed Description:
Evaluate clinical efficacy, microbiological efficacy and safety of Nemonoxacin adult patients with community-acquired pneumonia (CAP); and
A study on the population pharmacokinetics (PPK) of continuous oral administration of Nemonoxacin in adult patients with CAP.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- age of 18~70, BMI ≥ 18 kg/m2
- Female patients must avoid pregnancy
- Patients who are clinically diagnosed with community-acquired pneumonia (CAP)
- Chest X-ray shows inflammatory exudation or infiltration image.
- Patients who used antibacterial agents (excluding quinolones) within 72 hours before
- The patient's disease condition permits oral administration
Exclusion Criteria:
- Patients who have any of bronchiectasis and pulmonary disease.
- Hospitalized within 14 days before enrollment
- Have a history of allergy to any quinolone or fluoroquinolone antibiotic
- Patients who suffered uncontrolled mental disorders, epilepsy or central nervous system diseases.
- Renal, liver insufficiency
- Malabsorption syndrome or other gastrointestinal diseases
- Immune system diseases,such as a history of human immunodeficiency virus (HIV) infection,neutropenia or malignant tumor in the blood system or a solid organ, or removal of spleen
- Steroids longterm use, the dose is at least 20mg of prednisone daily
- Patients under critical condition.
- Shows significant abnormality of the cardiac conduction system (CCS) or other abnormalities, or prolonged QTc
- Have a medical history of prolonged QTc, or require concomitant medication of drugs that will lead to prolongation of QTc
- Patients who received chemotherapy or anti-tumor therapy within 6 months
- Alcohol abused or drugs banned
- Patients who used quinolones within two weeks before enrollment
- Donated more than 500ml of blood within 3 months
- co-medication of other antibacterial agents required.
- by investigators judgement,patient who increase the risk to the subjects or interfere with this clinical trial.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537250
Locations
| China | |
| Peking University People's Hospital | |
| Beijing, China | |
| Peking University First Hospital | |
| Beijing, China | |
| Zhen Hospital, Capital Medical University Beijing | |
| Beijing, China | |
| PLA Second Artillery General Hospital | |
| Beijing, China | |
| Beijing Chaoyang Hospital, Capital Medical University | |
| Beijing, China | |
| Beijing Union Medical College Hospital, Chinese Academy of Medical Sciences | |
| Beijing, China | |
| Daping Hospital, Third Military Medical University | |
| Chongqing, China | |
| First Affiliated Hospital of Fujian Medical University | |
| Fujian, China | |
| Gansu Provincial People's Hospital | |
| Gansu, China | |
| Second Affiliated Hospital of Sun Yat-sen | |
| Guangzhou, China | |
| Guangzhou Red Cross Hospital | |
| Guangzhou, China | |
| Affiliated Hospital of Guilin Medical College | |
| Guilin, China | |
| Taihe Hospital in Shiyan City, Hubei Province | |
| Hubei, China | |
| Third Xiangya Hospital, Central South University | |
| Hunan, China | |
| Second Affiliated Hospital of Nanchang University | |
| Jiangxi, China | |
| Jiangxi Provincial People's Hospital | |
| Jiangxi, China | |
| Jinan Central Hospital | |
| Jinan, China | |
| Shengjing Hospital of China Medical University | |
| Liaoning, China | |
| Nanjing General Hospital of Nanjing Military Region | |
| Nanjing, China | |
| Institute of Antibiotics, Huashan Hospital, Fundan University | |
| Shanghai, China | |
| Shanghai Pudong New Area, Oriental Hospital | |
| Shanghai, China | |
| Shanghai Putuo District Central Hospital | |
| Shanghai, China | |
| Huashan Hospital ,Fudan University | |
| Shanghai, China | |
| Institute of Antibiotics,Huashan Hospital ,Fudan University | |
| Shanghai,, China | |
| First Hospital of Shanxi Medical University | |
| Shanxi, China | |
| People's Liberation Army General Hospital of Shenyang Military Region | |
| Shenyang, China | |
| Shenzhen People's Hospital | |
| ShenZhen, China | |
| West China Hospital of Sichuan University (Respiratory) | |
| Sichuan, China | |
| Second Affiliated Hospital of Wenzhou Medical College | |
| Wenzhou, China | |
| Wuhan General Hospital of PLA Guangzhou Military Region | |
| Wuhan, China | |
| People's Hospital of Wuhan University | |
| Wuhan, China | |
| First Affiliated Hospital, Zhejiang University School of Medicine | |
| Zhejiang, China | |
Sponsors and Collaborators
TaiGen Biotechnology Co., Ltd.
Investigators
| Principal Investigator: | Yingyuan Zhang, PhD | Huashan Hospital, Fundan University |
More Information
No publications provided
| Responsible Party: | TaiGen Biotechnology Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01537250 History of Changes |
| Other Study ID Numbers: | TG-873870-C-3 |
| Study First Received: | February 5, 2012 |
| Last Updated: | February 16, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by TaiGen Biotechnology Co., Ltd.:
|
CAP |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Ofloxacin Anti-Bacterial Agents Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Urinary Renal Agents |
ClinicalTrials.gov processed this record on June 17, 2013