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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00979667
Other study ID # CCT2009-CS-6
Secondary ID
Status Terminated
Phase Phase 3
First received September 17, 2009
Last updated April 8, 2011
Start date October 2009
Est. completion date October 2010

Study information

Verified date May 2010
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Department of Health
Study type Interventional

Clinical Trial Summary

To evaluate the efficacy of oseltamivir ,as compared with the placebo arm and zanamivir with its control arm with respect to symptoms duration among patients infected with influenza A (H1N1) virus.


Description:

The outbreak of respiratory illnesses in Mexico that began in March 2009 was caused by a swine origin influenza A (H1N1) virus (S-OIV) that had not been recognized previously in pigs or humans. As of 17 May 2009, 39 countries have officially reported 8480 cases of influenza A (H1N1) infection.

The H1N1 influenza A virus appears sensitive to oseltamivir and zanamivir in vitro, but resistant to amantadine and rimantadine. This study is to test the oseltamivir, zanamivir and placebo arms as the first line treatment for human swine influenza infection. Through the study, the investigators may have better understanding about the clinical and, biochemical, virological profiles of oseltamivir/zanamivir on the H1N1 virus, and optimizing the treatment strategy among the Chinese population.


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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Oseltamivir
75 mg twice daily for 5 days
Zanamivir
10 mg twice daily for 5 days
Placebo of Oseltamivir
twice daily for 5 days

Locations

Country Name City State
China Shau Kei Wan Jockey Club Clinic Hong Kong Hong Kong
Hong Kong Fanling Family Medicine Centre Hong Kong
Hong Kong Sai Ying Pun Jockey Club General Outpatient Clinic Hong Kong

Sponsors (3)

Lead Sponsor Collaborator
Chinese University of Hong Kong Food and Health Bureau, Hong Kong, Hospital Authority

Countries where clinical trial is conducted

China,  Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to symptoms resolution as reported by the patient one week No
Secondary Treatment failure including hospitalization due to disease worsening. one week Yes
Secondary Viral load one week Yes
Secondary Severity of disease as measured by the patient diary and quality of life using SF12v2. one week Yes
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