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

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: NCT00380315
Recruitment Status : Completed
First Posted : September 25, 2006
Last Update Posted : July 2, 2009
Sponsor:
Information provided by:
Ahn-Gook Pharmaceuticals Co.,Ltd

Tracking Information
First Submitted Date  ICMJE September 21, 2006
First Posted Date  ICMJE September 25, 2006
Last Update Posted Date July 2, 2009
Study Start Date  ICMJE March 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2006)
Cough severity, Cough specific Quality of Life
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2009)
Daily cough symptom, Cough frequency
Original Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2006)
Daily cough syptom, Cough frequency
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of AG1321001 in Chronic Cougher
Official Title  ICMJE 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
Brief Summary This study is for therapeutic confirmation of AG1321001 to evaluate the safety and efficacy as an anti-tussive agent in cough patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cough
Intervention  ICMJE Drug: AG1321001(drug)
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
Actual Enrollment  ICMJE
 (submitted: September 21, 2006)
396
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (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 Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00380315
Other Study ID Numbers  ICMJE AG1321001_P302
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jung Hoon Han / Project Development Team
Study Sponsor  ICMJE Ahn-Gook Pharmaceuticals Co.,Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Ahn-Gook Pharmaceuticals Co.,Ltd
Verification Date June 2009

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