Clinical Trial to Evaluate the Safety and Efficacy of "Theobromine Capsule" as an Antitussive in Acute Cougher
Primary Purpose
Acute Bronchitis
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Theobromine 300mg
Levodropropizine 10mg
Sponsored by
About this trial
This is an interventional treatment trial for Acute Bronchitis focused on measuring Theobromine, cough, acute bronchitis
Eligibility Criteria
Inclusion Criteria:
- Patient who decided to participate in this clinical trial at his(her) own will and agreed in written letter of consent.
- Adult aged over 18
- Patient who has cough symptom caused by acute bronchitis
- Patient who go to see the doctor for severe cough at his(her) own will
- DCS score at screening vist sould be over 3.
- 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:
- Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as Acute infectious Pulmonary Disease, Tuberculosis, asthma.
- Chronic bronchitis including bronchial obstruction
- Patient who has clinical history of sensitivity to Xanthine drug.
- Patient who has Peptic Ulcer
- 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 convulsion or alcoholism.
- Patient who has experience to have participated in other clinical trial within two months before starting the trial.
- Pregnant woman, lactating woman.
- Patient who thought to be cured within 3 days without any medicine.
Sites / Locations
- Hallym University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Theobromine
levodropropizine
Arm Description
Theobromine capsule 300mg
levodropropizine syrup
Outcomes
Primary Outcome Measures
cough remission rate
cough remission : no cough or 1 short cough in day time
Secondary Outcome Measures
cough recovery rate
difference of DCS score between screening and closing visit.
required time for cough remission
Full Information
NCT ID
NCT01416480
First Posted
August 12, 2011
Last Updated
August 12, 2011
Sponsor
Ahn-Gook Pharmaceuticals Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01416480
Brief Title
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
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ahn-Gook Pharmaceuticals Co.,Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bronchitis
Keywords
Theobromine, cough, acute bronchitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
332 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Theobromine
Arm Type
Experimental
Arm Description
Theobromine capsule 300mg
Arm Title
levodropropizine
Arm Type
Active Comparator
Arm Description
levodropropizine syrup
Intervention Type
Drug
Intervention Name(s)
Theobromine 300mg
Intervention Description
Capsule, b.i.d.
Intervention Type
Drug
Intervention Name(s)
Levodropropizine 10mg
Intervention Description
Syrup, t.i.d.
Primary Outcome Measure Information:
Title
cough remission rate
Description
cough remission : no cough or 1 short cough in day time
Time Frame
3 days
Secondary Outcome Measure Information:
Title
cough recovery rate
Time Frame
1 day, 2 days, within 3days
Title
difference of DCS score between screening and closing visit.
Time Frame
3 days
Title
required time for cough remission
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient who decided to participate in this clinical trial at his(her) own will and agreed in written letter of consent.
Adult aged over 18
Patient who has cough symptom caused by acute bronchitis
Patient who go to see the doctor for severe cough at his(her) own will
DCS score at screening vist sould be over 3.
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:
Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as Acute infectious Pulmonary Disease, Tuberculosis, asthma.
Chronic bronchitis including bronchial obstruction
Patient who has clinical history of sensitivity to Xanthine drug.
Patient who has Peptic Ulcer
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 convulsion or alcoholism.
Patient who has experience to have participated in other clinical trial within two months before starting the trial.
Pregnant woman, lactating woman.
Patient who thought to be cured within 3 days without any medicine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki-Suck Jung, M.D.
Organizational Affiliation
Hallym University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Soo-Taek Uh, M.D.
Organizational Affiliation
Soon Chun Hyang University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jae Yeol Kim, M.D.
Organizational Affiliation
Chung-Ang University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Young Kyoon Kim, M.D.
Organizational Affiliation
The Catholic University of Korea-St. Mary's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sung Soon Lee, M.D.
Organizational Affiliation
Inje University Ilsan Paik Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yong Bum Park, M.D.
Organizational Affiliation
Kangdong Sacred Heart Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kwan Ho Lee, M.D.
Organizational Affiliation
Yeungnam University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jung Hyun chang, M.D.
Organizational Affiliation
Ewha Womans University Mokdong Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University Medical Center
City
Anyang
State/Province
Gyeonggi-do
ZIP/Postal Code
431-070
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial to Evaluate the Safety and Efficacy of "Theobromine Capsule" as an Antitussive in Acute Cougher
We'll reach out to this number within 24 hrs