Clinical Trial to Evaluate the Safety and Efficacy of "Theobromine Capsule" as an Antitussive in Acute Cougher
This study has been completed.
Sponsor:
Ahn-Gook Pharmaceuticals Co.,Ltd
Information provided by:
Ahn-Gook Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01416480
First received: August 12, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
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Purpose
The aim of this clinical trial is to evaluate the antitussive effect of "Theobromine capsule 300mg" in patients with acute bronchitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Bronchitis |
Drug: Theobromine 300mg Drug: Levodropropizine 10mg |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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. |
Resource links provided by NLM:
Drug Information available for:
Guaifenesin
Phenylpropanolamine hydrochloride
Triaminic
Phenylpropanolamine
U.S. FDA Resources
Further study details as provided by Ahn-Gook Pharmaceuticals Co.,Ltd:
Primary Outcome Measures:
- cough remission rate [ Time Frame: 3 days ] [ Designated as safety issue: No ]cough remission : no cough or 1 short cough in day time
Secondary Outcome Measures:
- cough recovery rate [ Time Frame: 1 day, 2 days, within 3days ] [ Designated as safety issue: No ]
- difference of DCS score between screening and closing visit. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
- required time for cough remission [ Time Frame: 3 days ] [ Designated as safety issue: No ]
| Enrollment: | 332 |
| Study Start Date: | May 2010 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Theobromine
Theobromine capsule 300mg
|
Drug: Theobromine 300mg
Capsule, b.i.d.
|
|
Active Comparator: levodropropizine
levodropropizine syrup
|
Drug: Levodropropizine 10mg
Syrup, t.i.d.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416480
Locations
| Korea, Republic of | |
| 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 |
| Principal Investigator: | Jung Hyun chang, M.D. | Ewha Womans University |
More Information
No publications provided
| Responsible Party: | Jung Hoon, Han / Senior Researcher, Project Development Team / Ahn-Gook Pharmaceuticals Co.,Ltd |
| ClinicalTrials.gov Identifier: | NCT01416480 History of Changes |
| Other Study ID Numbers: | AG1321001_ACP3 |
| Study First Received: | August 12, 2011 |
| Last Updated: | August 12, 2011 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Ahn-Gook Pharmaceuticals Co.,Ltd:
|
Theobromine cough acute bronchitis |
Additional relevant MeSH terms:
|
Bronchitis Acute Disease Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections Disease Attributes Pathologic Processes Dipropizine Antitussive Agents Guaifenesin Phenylpropanolamine Theobromine Chlorpheniramine, phenylpropanolamine drug combination |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Respiratory System Agents Expectorants Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Appetite Depressants Anti-Obesity Agents Sympathomimetics Autonomic Agents |
ClinicalTrials.gov processed this record on June 17, 2013