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

June 30, 2009 updated by: Ahn-Gook Pharmaceuticals Co.,Ltd

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

396

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Cough severity, Cough specific Quality of Life

Secondary Outcome Measures

Outcome Measure
Daily cough symptom, Cough frequency

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Investigators

  • Study Chair: Young-hwan Kim, MD, PhD, Seoul National University Hospital, Seoul, 110-744, Korea, Republic of
  • Principal Investigator: Choon-Taek Lee, MD, PhD, Seoul National University Bundang Hospital, Sungnam, Korea, Republic of
  • Principal Investigator: Hee-Soon Chung, MD, PhD, Seoul National University Boramae Hospital, Seoul, 156-707, Korea, Republic of
  • Principal Investigator: Ki-suk Jung, MD, PhD, Hallym University Sacred Heart Hospital, Anyang, Kyunggi, 430-070, Korea, Republic of
  • Principal Investigator: Joon Chang, MD, PhD, Severance Hospital, Seoul, 120-752, Korea, Republic of
  • Principal Investigator: Chul-min Ahn, MD, PhD, Yongdong Sevenrance Hospital, Seoul, 135-720, Korea, Republic of

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion (ACTUAL)

June 1, 2007

Study Registration Dates

First Submitted

September 21, 2006

First Submitted That Met QC Criteria

September 21, 2006

First Posted (ESTIMATE)

September 25, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

July 2, 2009

Last Update Submitted That Met QC Criteria

June 30, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG1321001_P302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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