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

NCT00547846 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2009-01-12

No results posted yet for this study

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.

Conditions

  • Acute Cough

Interventions

DRUG

PDC-748

Sponsors & Collaborators

  • PhytoHealth Corporation

    lead INDUSTRY

Principal Investigators

  • Ying-Huang Tsai, M.D. · Chang Gung Memorial Hospital

  • Ying Huang Tsai, PI · Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31

Countries

  • Taiwan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00547846 on ClinicalTrials.gov