Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of AG1321001 in Chron… (NCT00380315) | Clinical Trial Compass
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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.