CompletedPhase 3

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

South Korea396 participantsStarted 2006-03

Plain-language summary

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

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adult between the ages of 18 and 70.
✓. Patient who has cough symptom caused by following diseases: chronic bronchitis, bronchiectasis, gastroesophageal reflux disease, postnasal drip syndrome caused by rhinitis, sinusitis, rhinopharyngitis, rhinolaryngitis.
✓. Patient requiring internal treatment due to cough symptom, who has coughing more than 3 weeks.
✓. patient who will continue to cough more than 1 week.(by physician's judgment)
✓. Patient who decided to participate in this clinical trial at his(her) own will and agreed in written letter of consent.
✓. Patient who is trustworthy, ready for cooperation and observing the restrictions during the trial period.

✕. Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as Acute infectious Pulmonary Disease, Tuberculosis.
✕. Patient who has clinical history of sensitivity to Xanthine drug.
✕. Patient who has Peptic Ulcer or Asthma (Except Cicatrix)
✕. 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.
✕. Patient whose heart function is abnormal: including the case of showing abnormal EKG test value that is clinically significant.
✕. Patient who has experience to have participated in other clinical trial within two months before starting the trial.
✕. Pregnant woman, lactating woman.
✕. patient who has convulsion or alcoholism.

Cough severity, Cough specific Quality of Life

NCT IDNCT00380315

SponsorAhn-Gook Pharmaceuticals Co.,Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adult between the ages of 18 and 70.
✓. Patient who has cough symptom caused by following diseases: chronic bronchitis, bronchiectasis, gastroesophageal reflux disease, postnasal drip syndrome caused by rhinitis, sinusitis, rhinopharyngitis, rhinolaryngitis.
✓. Patient requiring internal treatment due to cough symptom, who has coughing more than 3 weeks.
✓. patient who will continue to cough more than 1 week.(by physician's judgment)
✓. Patient who decided to participate in this clinical trial at his(her) own will and agreed in written letter of consent.
✓. Patient who is trustworthy, ready for cooperation and observing the restrictions during the trial period.

✕. Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as Acute infectious Pulmonary Disease, Tuberculosis.
✕. Patient who has clinical history of sensitivity to Xanthine drug.
✕. Patient who has Peptic Ulcer or Asthma (Except Cicatrix)
✕. 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.
✕. Patient whose heart function is abnormal: including the case of showing abnormal EKG test value that is clinically significant.
✕. Patient who has experience to have participated in other clinical trial within two months before starting the trial.
✕. Pregnant woman, lactating woman.
✕. patient who has convulsion or alcoholism.