Acute Cough Clinical Trial
Official title:
A Phase II Clinical Study of PDC-748 in Patients With Acute Cough
The pharmacological effects of PDC-748 were tested in numerous in vitro and in vivo studies.
The existing pharmacologic findings suggest that PDC-748 possesses certain inhibitory
activity to the citric acid- and capsaicin-induced cough reflex in guinea pigs with a
dose-dependent manner. Furthermore, a previous Phase I/II uncontrolled, dose-escalating
study has shown PDC-748 to be well tolerated and may help to alleviate daytime cough with a
dose-responding manner.Hence, PhytoHealth Corporation intends to carry out a Phase II
investigation to confirm the preliminary findings using placebo in the comparator group, and
to further investigate PDC-748 with a dose escalating manner to establish the dose-response
range for its antitussive effect, and if possible, to determine the maximal tolerable dose
of PDC-748.
This is a randomized, double-blind, placebo-controlled, dose escalating study to evaluate
the safety and efficacy of the escalating dose levels of PDC-748 in patients with acute
cough.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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