Zhonghua nei ke za zhi · 2002
[An open label multi-center clinical trial to evaluate the efficacy of compound pseudoephedrine [corrected] hydrochloride sustained release capsules in patients with nasal symptoms associated with common cold].
Клиническое исследованиеАннотация на английскомСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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New Contac Multi-Center Clinical Cooperative Group, Xiao Zhenglun
Аннотация
OBJECTIVE: To evaluate the efficacy and safety of compound pseudoephedrine [corrected] hydrochloride (New Contact sustained release capsules) in the treatment of the nasal symptoms associated with common cold or influenza.
METHOD: Open label multi-center clinical trial was adopted: one capsule twice daily with an interval of 12 hours, successively for 4 days to treat the nasal symptoms associated with common cold or influenza.
RESULTS: A total of 416 patients were eligible for efficacy and safety analysis. The cure rates for nasal congestion from day 1 to day 4 were 7%, 31%, 64% and 88%, cumulatively; for runny nose were 9%, 36%, 68% and 89%; for sneezing were 20%, 51%, 76% and 93%, and for watery eyes were 36%, 68%, 89% and 96%, respectively. There were no serious adverse events during the study. Forty adverse events (AE's) with an incidence of 8% were developed in 35 patients. The most frequent AE's were drowsiness (24/416, 6%) and dry mouth (5/416, 1%). All AE's were in mild or moderate degree.
CONCLUSION: The results indicated that New Contact sustained released capsule was effective in controlling the nasal symptoms associated with common cold or influenza and it was well-tolerated.
METHOD: Open label multi-center clinical trial was adopted: one capsule twice daily with an interval of 12 hours, successively for 4 days to treat the nasal symptoms associated with common cold or influenza.
RESULTS: A total of 416 patients were eligible for efficacy and safety analysis. The cure rates for nasal congestion from day 1 to day 4 were 7%, 31%, 64% and 88%, cumulatively; for runny nose were 9%, 36%, 68% and 89%; for sneezing were 20%, 51%, 76% and 93%, and for watery eyes were 36%, 68%, 89% and 96%, respectively. There were no serious adverse events during the study. Forty adverse events (AE's) with an incidence of 8% were developed in 35 patients. The most frequent AE's were drowsiness (24/416, 6%) and dry mouth (5/416, 1%). All AE's were in mild or moderate degree.
CONCLUSION: The results indicated that New Contact sustained released capsule was effective in controlling the nasal symptoms associated with common cold or influenza and it was well-tolerated.