Clinical trial NCT00380315: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cough
Keywords: Cough
Chronic bronchitis
PNDs
Post Nasal Drip syndrome
GERD
gastroesophageal reflux disease
bronchiectasis
Lead sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2006-09-25
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Cough severity, Cough specific Quality of Life
Secondary outcomes:
measure: Daily cough symptom, Cough frequency
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital, Seoul, 110-744, Korea, Republic of
name: Young-hwan Kim, MD, PhD
role: STUDY_CHAIR
affiliation: Seoul National University Bundang Hospital, Sungnam, Korea, Republic of
name: Choon-Taek Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Boramae Hospital, Seoul, 156-707, Korea, Republic of
name: Hee-Soon Chung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University Sacred Heart Hospital, Anyang, Kyunggi, 430-070, Korea, Republic of
name: Ki-suk Jung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Hospital, Seoul, 120-752, Korea, Republic of
name: Joon Chang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yongdong Sevenrance Hospital, Seoul, 135-720, Korea, Republic of
name: Chul-min Ahn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: