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Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of AG1321001 in Chronic Cougher
This study is currently recruiting participants.
Verified by Ahn-Gook Pharmaceuticals Co.,Ltd, September 2006
Sponsored by: Ahn-Gook Pharmaceuticals Co.,Ltd
Information provided by: Ahn-Gook Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT00380315
  Purpose

This study is for therapeutic confirmation of AG1321001 to evaluate the safety and efficacy as an anti-tussive agent in cough patients.


Condition Intervention Phase
Cough
Drug: AG1321001(drug)
Phase III

MedlinePlus related topics: Cough
Drug Information available for: Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of AG1321001 Capsule as an Anti-Tussive Agent in Cough Patients: Double Blinded, Randomized, Placebo and Active Rug Comparative, Parallel Designed Phase III Study

Further study details as provided by Ahn-Gook Pharmaceuticals Co.,Ltd:

Primary Outcome Measures:
  • Cough severity, Cough specific Quality of Life

Secondary Outcome Measures:
  • Daily cough syptom, Cough frequency

Estimated Enrollment: 396
Study Start Date: March 2006
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult between the ages of 18 and 60.
  2. patient who has cough symptom caused by following diaseses: Chronic Bronchitis, Asthma, Bronchiectasis, Gastroesophargeal Reflux Disease, Postnasal drip syndrom caused by rhinitis, sinusitis, rhinopharyngitis, rhinolayngitis.
  3. Patient requiring internal treatment due to cough symptom, who has coughing more than 3 weeks.
  4. Patinet who decided to participate in theis clinical trial at his(her) own will and agreed in written letter of consent.
  5. Patient who is trustworthy, ready for cooperation and observing the restrictions during the trial period.

Exclusion Criteria:

  1. Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as Acute infectious Pulmonary Disease, Tuberculosis.
  2. Patient who has clinical history of sensitivity to Xanthine drug.
  3. Patient who pas Peptic Ulcer (Except Cicatrix)
  4. Patient whose liver or kidney function is seriously abnormal: Including the cases of sGOT, sGPT, bilirubin and blood creatinine value exveeding twice of their upper normal limit.
  5. Patient whose heart function is abnormal: including the case of showing abnormal EKG test value that is clinically significant.
  6. Patient who has experinece to have participated in other clinical trial whithin two months before starting the trial.
  7. Pregnant woman, latating woman.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00380315

Contacts
Contact: Sungjin Kim, Assistant manager 82-2-3289-4260 agc&techpd@ahn-gook.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 82
Contact: Sungjin Kim, Assistant manager     82-2-3289-4260     agc&techpd@ahn-gook.com    
Principal Investigator: Young-Hwan Kim, MD, PhD            
Sponsors and Collaborators
Ahn-Gook Pharmaceuticals Co.,Ltd
Investigators
Study Chair: Young-hwan Kim, MD, PhD Seoul National University Hospital, Seoul, 110-744, Korea, Republic of
Principal Investigator: Choon-Taek Lee, MD, PhD Seoul National University Bundang Hospital, Sungnam, Korea, Republic of
Principal Investigator: Hee-Soon Chung, MD, PhD Seoul National University Boramae Hospital, Seoul, 156-707, Korea, Republic of
Principal Investigator: Ki-suk Jung, MD, PhD Hallym University Sacred Heart Hospital, Anyang, Kyunggi, 430-070, Korea, Republic of
Principal Investigator: Joon Chang, MD, PhD Severance Hospital, Seoul, 120-752, Korea, Republic of
Principal Investigator: Chul-min Ahn, MD, PhD Yongdong Sevenrance Hospital, Seoul, 135-720, Korea, Republic of
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: AG1321001_P302
Study First Received: September 21, 2006
Last Updated: September 21, 2006
ClinicalTrials.gov Identifier: NCT00380315  
Health Authority: South Korea: Korea Food and Drug Administration (KFDA);   United States: Food and Drug Administration

Keywords provided by Ahn-Gook Pharmaceuticals Co.,Ltd:
Cough, Asthma, bronchitis, PNDs(PostNasal Drip syndrome), GERD(Gastro Esophargeal Reflux Disease)

Study placed in the following topic categories:
Naphazoline
Oxymetazoline
Signs and Symptoms
Respiratory Tract Diseases
Guaifenesin
Phenylephrine
Respiration Disorders
Signs and Symptoms, Respiratory
Cough
Asthma
Bronchitis
Phenylpropanolamine

ClinicalTrials.gov processed this record on January 16, 2009