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Completed

NCT Number: NCT00380315

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • 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.
  • patient who take medicines which can not use combination with AG1321001.

Treatment and study plan

AG1321001(drug)

Drug

Primary outcomes

  1. Cough severity, Cough specific Quality of Life

Secondary outcomes

  1. Daily cough symptom, Cough frequency

Sponsors and collaborators

Lead sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2007
First posted
Sep 25, 2006
Registry last updated
Jul 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.