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

Phase 3

Completed

• Conditions: Acute Bronchitis
• Interventions: Drug: Levodropropizine 10mg; Drug: Theobromine 300mg

• Registration Number: NCT01416480
• Lead Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd

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.

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2011-02
• Study Completion: 2011-05
• Status Verified: 2011-08
• Study First Submitted: 2011-08-12
• Study First Submitted QC: 2011-08-12
• Last Update Submitted: 2011-08-12
• Study First Posted: 2011-08-15
• Last Update Posted: 2011-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 332

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
levodropropizine	Levodropropizine 10mg	levodropropizine syrup
Theobromine	Theobromine 300mg	Theobromine capsule 300mg

Primary Outcome Measures

Name	Time	Method
cough remission rate	3 days	cough remission : no cough or 1 short cough in day time

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hallym University Medical Center; 🇰🇷 Anyang, Gyeonggi-do, Korea, Republic of