Abstract | 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.
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Authors | New Contac Multi-Center Clinical Cooperative Group, Zhenglun Xiao |
Journal | Zhonghua nei ke za zhi
(Zhonghua Nei Ke Za Zhi)
Vol. 41
Issue 8
Pg. 547-9
(Aug 2002)
ISSN: 0578-1426 [Print] China |
PMID | 12421505
(Publication Type: Clinical Trial, English Abstract, Journal Article, Multicenter Study)
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Chemical References |
- Delayed-Action Preparations
- Nasal Decongestants
- Phenylpropanolamine
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Topics |
- Adolescent
- Adult
- Aged
- Common Cold
(complications, drug therapy)
- Delayed-Action Preparations
- Female
- Humans
- Influenza, Human
(complications, drug therapy)
- Male
- Middle Aged
- Nasal Decongestants
(adverse effects, therapeutic use)
- Nasal Obstruction
(drug therapy, etiology)
- Phenylpropanolamine
(adverse effects, therapeutic use)
- Sleep Wake Disorders
(chemically induced)
- Sneezing
(drug effects)
- Treatment Outcome
- Xerostomia
(chemically induced)
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