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

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

Condition or disease Intervention/treatment Phase
Cough Drug: AG1321001(drug) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 396 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : March 2006
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Cough severity, Cough specific Quality of Life

Secondary Outcome Measures :
  1. Daily cough symptom, Cough frequency

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00380315

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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 82
Sponsors and Collaborators
Ahn-Gook Pharmaceuticals Co.,Ltd
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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
Additional Information:
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Responsible Party: Jung Hoon Han / Project Development Team Identifier: NCT00380315    
Other Study ID Numbers: AG1321001_P302
First Posted: September 25, 2006    Key Record Dates
Last Update Posted: July 2, 2009
Last Verified: June 2009
Keywords provided by Ahn-Gook Pharmaceuticals Co.,Ltd:
Chronic bronchitis
Post Nasal Drip syndrome
gastroesophageal reflux disease
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms