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

Primary Purpose

Cough

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

AG1321001(drug)

About this trial

This is an interventional treatment trial for Cough focused on measuring Cough, Chronic bronchitis, PNDs, Post Nasal Drip syndrome, GERD, gastroesophageal reflux disease, bronchiectasis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Seoul National University Hospital

Outcomes

Primary Outcome Measures

Cough severity, Cough specific Quality of Life

Secondary Outcome Measures

Daily cough symptom, Cough frequency

Full Information

NCT ID

NCT00380315

First Posted

September 21, 2006

Last Updated

June 30, 2009

Sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

1. Study Identification

Unique Protocol Identification Number

NCT00380315

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cough

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

396 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

AG1321001(drug)

Primary Outcome Measure Information:

Title

Cough severity, Cough specific Quality of Life

Secondary Outcome Measure Information:

Title

Daily cough symptom, Cough frequency

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: