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

NCT00380315 | Completed Phase 3

• 1 other identifier: AG1321001_P302
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cough

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cough severity, Cough specific Quality of Life

Secondary Outcomes (1)

• Daily cough symptom, Cough frequency

Interventions

AG1321001(drug) DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahn-Gook Pharmaceuticals Co.,Ltd: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 82, South Korea

Location

Related Links

• Related Info

MeSH Terms

Conditions

Cough; Bronchitis, Chronic; upper airway cough syndrome; Gastroesophageal Reflux; Bronchiectasis

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Young-hwan Kim, MD, PhD

  Seoul National University Hospital, Seoul, 110-744, Korea, Republic of

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 21, 2006
• First Posted: September 25, 2006
• Study Start: March 1, 2006
• Study Completion: June 1, 2007
• Last Updated: July 2, 2009

Record last verified: 2009-06

Locations

KR (1)