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

Cough Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00380315
• Other study ID #: AG1321001_P302
• Status: Completed
• Phase: Phase 3
• First received: September 21, 2006
• Last updated: June 30, 2009
• Start date: March 2006
• Est. completion date: June 2007

Study information

• Verified date: June 2009
• Source: Ahn-Gook Pharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cough

Intervention

Drug:
• AG1321001(drug)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ahn-Gook Pharmaceuticals Co.,Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cough severity, Cough specific Quality of Life
Secondary	Daily cough symptom, Cough frequency

External Links

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