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

Primary Purpose

Acute Cough

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
PDC-748
Sponsored by
PhytoHealth Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Cough focused on measuring Cough, Antitussive, PDC-748, PhytoHealth

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chang-Gung Memorial Hospital,Taiwan

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 22, 2007
Last Updated
January 8, 2009
Sponsor
PhytoHealth Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00547846
Brief Title
A Phase II Clinical Study of PDC-748 in Patients With Acute Cough
Official Title
A Phase II Clinical Study of PDC-748 in Patients With Acute Cough
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
PhytoHealth Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cough
Keywords
Cough, Antitussive, PDC-748, PhytoHealth

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
PDC-748

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying-Huang Tsai, M.D.
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ying Huang Tsai, PI
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang-Gung Memorial Hospital,Taiwan
City
Taipei city/ Taoyuan County
State/Province
Taiwan,ROC
ZIP/Postal Code
105
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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