Clinical trial NCT01416480: Clinical Trial to Evaluate the Safety and Efficacy of "Theobromine Capsule" as an Antitussive in Acute Cougher
Official title: Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Theobromine Capsule 300mg" as an Antitussive Agent in Acute Cough Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Bronchitis
Keywords: Theobromine
cough
acute bronchitis
Lead sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2011-08-15
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical trial is to evaluate the antitussive effect of "Theobromine capsule 300mg" in patients with acute bronchitis.

Detailed description: This study is double blinded, randomized, parallel designed, phase III clinical trial to evaluate the efficacy and safety of "Theobromine capsule 300mg" versus "Levodropropizine syrup" in patients with acute bronchitis.

Eligibility criteria: Inclusion Criteria:

1. Patient who decided to participate in this clinical trial at his(her) own will and agreed in written letter of consent.
2. Adult aged over 18
3. Patient who has cough symptom caused by acute bronchitis
4. Patient who go to see the doctor for severe cough at his(her) own will
5. DCS score at screening vist sould be over 3.
6. For fertile woman, HCG test at screening visit shloud be negative.

patient who will continue to cough more than 1 week.(by physician's judgment)

Exclusion Criteria:

1. Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as Acute infectious Pulmonary Disease, Tuberculosis, asthma.
2. Chronic bronchitis including bronchial obstruction
3. Patient who has clinical history of sensitivity to Xanthine drug.
4. Patient who has Peptic Ulcer
5. 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.
6. Patient whose heart function is abnormal: including the case of showing abnormal EKG test value that is clinically significant.
7. patient who has convulsion or alcoholism.
8. Patient who has experience to have participated in other clinical trial within two months before starting the trial.
9. Pregnant woman, lactating woman.
10. Patient who thought to be cured within 3 days without any medicine.

Primary outcomes:
measure: cough remission rate
timeFrame: 3 days
Secondary outcomes:
measure: cough recovery rate
timeFrame: 1 day, 2 days, within 3days
measure: difference of DCS score between screening and closing visit.
timeFrame: 3 days
measure: required time for cough remission
timeFrame: 3 days
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Medical Center
state: Gyeonggi-do
Study officials:
affiliation: Hallym University Medical Center
name: Ki-Suck Jung, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Soon Chun Hyang University Hospital
name: Soo-Taek Uh, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chung-Ang University Medical Center
name: Jae Yeol Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea-St. Mary's Hospital
name: Young Kyoon Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University Ilsan Paik Hospital
name: Sung Soon Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kangdong Sacred Heart Hospital
name: Yong Bum Park, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeungnam University Hospital
name: Kwan Ho Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ewha Womans University Mokdong Hospital
name: Jung Hyun chang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: