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

Acute Bronchitis Clinical Trial

Official title:

Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Theobromine Capsule 300mg" as an Antitussive Agent in Acute Cough Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01416480
• Other study ID #: AG1321001_ACP3
• Status: Completed
• Phase: Phase 3
• First received: August 12, 2011
• Last updated: August 12, 2011
• Start date: May 2010
• Est. completion date: May 2011

Study information

• Verified date: August 2011
• Source: Ahn-Gook Pharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: May 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Bronchitis
• Bronchitis

Intervention

Drug:
• Theobromine 300mg
Capsule, b.i.d.
• Levodropropizine 10mg
Syrup, t.i.d.

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Medical Center	Anyang	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Ahn-Gook Pharmaceuticals Co.,Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cough remission rate	cough remission : no cough or 1 short cough in day time	3 days	No
Secondary	cough recovery rate		1 day, 2 days, within 3days	No
Secondary	difference of DCS score between screening and closing visit.		3 days	No
Secondary	required time for cough remission		3 days	No