A Phase II Clinical Study of PDC-748 in Patients With Acute Cough

2014-08-26 22:35:30 | BioPortfolio

Summary

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Acute Cough

Intervention

PDC-748

Location

Chang-Gung Memorial Hospital,Taiwan
Taipei city/ Taoyuan County
Taiwan,ROC
Taiwan
105

Status

Completed

Source

PhytoHealth Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-26T22:35:30-0400

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