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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00547846
Recruitment Status : Completed
First Posted : October 23, 2007
Last Update Posted : January 12, 2009
Sponsor:
Information provided by:
PhytoHealth Corporation

Tracking Information
First Submitted Date  ICMJE October 22, 2007
First Posted Date  ICMJE October 23, 2007
Last Update Posted Date January 12, 2009
Study Start Date  ICMJE October 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase II Clinical Study of PDC-748 in Patients With Acute Cough
Official Title  ICMJE A Phase II Clinical Study of PDC-748 in Patients With Acute Cough
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Cough
Intervention  ICMJE Drug: PDC-748
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00547846
Other Study ID Numbers  ICMJE PH-CP013
SBIR: 2Z950430
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE PhytoHealth Corporation
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ying-Huang Tsai, M.D. Chang Gung Memorial Hospital
Principal Investigator: Ying Huang Tsai, PI Chang Gung Memorial Hospital
PRS Account PhytoHealth Corporation
Verification Date January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP