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

This study has been completed.
Sponsor:
Information provided by:
PhytoHealth Corporation
ClinicalTrials.gov Identifier:
NCT00547846
First received: October 22, 2007
Last updated: January 8, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention Phase
Acute Cough
Drug: PDC-748
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Study of PDC-748 in Patients With Acute Cough

Resource links provided by NLM:


Further study details as provided by PhytoHealth Corporation:

Study Start Date: October 2007
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547846

Locations
Taiwan
Chang-Gung Memorial Hospital,Taiwan
Taipei city/ Taoyuan County, Taiwan,ROC, Taiwan, 105
Sponsors and Collaborators
PhytoHealth Corporation
Investigators
Principal Investigator: Ying-Huang Tsai, M.D. Chang Gung Memorial Hospital
Principal Investigator: Ying Huang Tsai, PI Chang Gung Memorial Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00547846     History of Changes
Other Study ID Numbers: PH-CP013, SBIR: 2Z950430
Study First Received: October 22, 2007
Last Updated: January 8, 2009
Health Authority: United States: Food and Drug Administration
Taiwan: Department of Health

Keywords provided by PhytoHealth Corporation:
Cough
Antitussive
PDC-748
PhytoHealth

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on September 15, 2014