Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of AG1321001 in Chronic Cougher

This study has been completed.
Sponsor:
Information provided by:
Ahn-Gook Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier:
NCT00380315
First received: September 21, 2006
Last updated: June 30, 2009
Last verified: June 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 symptom, Cough frequency

Enrollment: 396
Study Start Date: March 2006
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult between the ages of 18 and 70.
  2. Patient who has cough symptom caused by following diseases: chronic bronchitis, bronchiectasis, gastroesophageal reflux disease, postnasal drip syndrome caused by rhinitis, sinusitis, rhinopharyngitis, rhinolaryngitis.
  3. Patient requiring internal treatment due to cough symptom, who has coughing more than 3 weeks.
  4. patient who will continue to cough more than 1 week.(by physician's judgment)
  5. Patient who decided to participate in this clinical trial at his(her) own will and agreed in written letter of consent.
  6. 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 has Peptic Ulcer or Asthma (Except Cicatrix)
  4. Patient whose liver or kidney function is seriously abnormal: Including the cases of sGOT, sGPT, bilirubin and blood creatinine value exceeding 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 experience to have participated in other clinical trial within two months before starting the trial.
  7. Pregnant woman, lactating woman.
  8. patient who has convulsion or alcoholism.
  9. patient who take medicines which can not use combination with AG1321001.
  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: NCT00380315

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 82
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

Additional Information:
No publications provided

Responsible Party: Jung Hoon Han / Project Development Team
ClinicalTrials.gov Identifier: NCT00380315     History of Changes
Other Study ID Numbers: AG1321001_P302
Study First Received: September 21, 2006
Last Updated: June 30, 2009
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
Chronic bronchitis
PNDs
Post Nasal Drip syndrome
GERD
gastroesophageal reflux disease
bronchiectasis

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

ClinicalTrials.gov processed this record on October 20, 2014