Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of AG1321001 in Chronic Cougher
Information source: Ahn-Gook Pharmaceuticals Co.,Ltd
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cough
Intervention: AG1321001(drug) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Ahn-Gook Pharmaceuticals Co.,Ltd Official(s) and/or principal investigator(s): Young-hwan Kim, MD, PhD, Study Chair, Affiliation: Seoul National University Hospital, Seoul, 110-744, Korea, Republic of Choon-Taek Lee, MD, PhD, Principal Investigator, Affiliation: Seoul National University Bundang Hospital, Sungnam, Korea, Republic of Hee-Soon Chung, MD, PhD, Principal Investigator, Affiliation: Seoul National University Boramae Hospital, Seoul, 156-707, Korea, Republic of Ki-suk Jung, MD, PhD, Principal Investigator, Affiliation: Hallym University Sacred Heart Hospital, Anyang, Kyunggi, 430-070, Korea, Republic of Joon Chang, MD, PhD, Principal Investigator, Affiliation: Severance Hospital, Seoul, 120-752, Korea, Republic of Chul-min Ahn, MD, PhD, Principal Investigator, Affiliation: Yongdong Sevenrance Hospital, Seoul, 135-720, Korea, Republic of
Summary
This study is for therapeutic confirmation of AG1321001 to evaluate the safety and efficacy
as an anti-tussive agent in cough patients.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Cough severity, Cough specific Quality of Life
Secondary outcome: Daily cough symptom, Cough frequency
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
Seoul National University Hospital, Seoul 82, Korea, Republic of
Additional Information
Starting date: March 2006
Last updated: June 30, 2009
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