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

January 8, 2009 updated by: PhytoHealth Corporation

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with acute cough ;
  • Men or women aged ≥ 20 years old;
  • Patients with Cough Symptom Score(daytime) between 2 and 4, inclusively;
  • Patients are willing and able to comply with the study procedures and sign the informed consent.

Exclusion Criteria:

  • Patients with chronic cough ;
  • Patients with chronic airway disease;
  • Patients with respiratory tract malignancy;
  • Patients with clinically suspected low respiratory tract infection;
  • Patients with abnormal liver or kidney functions
  • Patients taking antitussives, sleeping pills, sedative medications, or herbal products;
  • Pregnant or breastfeeding patients; female patients of child bearing potential who do not agree to practice effective birth control;
  • Patient's symptom of acute cough may be due to heart failure or may be induced by other medications such as ACE inhibitor medications, as determined by the investigator;
  • Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with the assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, or hematological disease as determined by the clinical judgment of the investigator;
  • Use of any investigational drug or participation of any clinical trial within 28 days prior to this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PhytoHealth Corporation

Investigators

  • Principal Investigator: Ying-Huang Tsai, M.D., Chang Gung Memorial Hospital
  • Principal Investigator: Ying Huang Tsai, PI, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Study Registration Dates

First Submitted

October 22, 2007

First Submitted That Met QC Criteria

October 22, 2007

First Posted (Estimate)

October 23, 2007

Study Record Updates

Last Update Posted (Estimate)

January 12, 2009

Last Update Submitted That Met QC Criteria

January 8, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PH-CP013
  • SBIR: 2Z950430

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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