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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00380315

Enrollment

396

Registered

2006-09-25

Start date

2006-03-31

Completion date

2007-06-30

Last updated

2009-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough

Keywords

Cough, Chronic bronchitis, PNDs, Post Nasal Drip syndrome, GERD, gastroesophageal reflux disease, bronchiectasis

Brief summary

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

Interventions

DRUGAG1321001(drug)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Cough severity, Cough specific Quality of Life	—

Secondary

Measure	Time frame
Daily cough symptom, Cough frequency	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026