Clinical Trial to Evaluate the Safety and Efficacy of "Theobromine Capsule" as an Antitussive in Acute Cougher

Sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT01416480

Collaborator

(none)

332

Enrollment

Location

Arms

Duration (Months)

27.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Bronchitis	Drug: Theobromine 300mg Drug: Levodropropizine 10mg	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

332 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2010

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Theobromine Theobromine capsule 300mg	Drug: Theobromine 300mg Capsule, b.i.d.
Active Comparator: levodropropizine levodropropizine syrup	Drug: Levodropropizine 10mg Syrup, t.i.d.

Arm

Intervention/Treatment

Experimental: Theobromine

Theobromine capsule 300mg

Drug: Theobromine 300mg

Capsule, b.i.d.

Active Comparator: levodropropizine

levodropropizine syrup

Drug: Levodropropizine 10mg

Syrup, t.i.d.

Outcome Measures

Primary Outcome Measures

cough remission rate [3 days]
cough remission : no cough or 1 short cough in day time

Secondary Outcome Measures

cough recovery rate [1 day, 2 days, within 3days]
difference of DCS score between screening and closing visit. [3 days]
required time for cough remission [3 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hallym University Medical Center	Anyang	Gyeonggi-do	Korea, Republic of	431-070

Sponsors and Collaborators

Ahn-Gook Pharmaceuticals Co.,Ltd

Investigators

Principal Investigator: Ki-Suck Jung, M.D., Hallym University Medical Center
Principal Investigator: Soo-Taek Uh, M.D., Soon Chun Hyang University Hospital
Principal Investigator: Jae Yeol Kim, M.D., Chung-Ang University Medical Center
Principal Investigator: Young Kyoon Kim, M.D., The Catholic University of Korea-St. Mary's Hospital
Principal Investigator: Sung Soon Lee, M.D., Inje University
Principal Investigator: Yong Bum Park, M.D., Kangdong Sacred Heart Hospital
Principal Investigator: Kwan Ho Lee, M.D., Yeungnam University Hospital
Principal Investigator: Jung Hyun chang, M.D., Ewha Womans University Mokdong Hospital