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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| First Received Date ICMJE | August 12, 2011 | ||||||||||||||||||||||||||||||||
| Last Updated Date | August 12, 2011 | ||||||||||||||||||||||||||||||||
| Start Date ICMJE | May 2010 | ||||||||||||||||||||||||||||||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
cough remission rate [ Time Frame: 3 days ] [ Designated as safety issue: No ] cough remission : no cough or 1 short cough in day time |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||||||||||
| Change History | No Changes Posted | ||||||||||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||||||||||
| Brief Title ICMJE | Clinical Trial to Evaluate the Safety and Efficacy of "Theobromine Capsule" as an Antitussive in Acute Cougher | ||||||||||||||||||||||||||||||||
| Official Title ICMJE | Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Theobromine Capsule 300mg" as an Antitussive Agent in Acute Cough Patients. | ||||||||||||||||||||||||||||||||
| Brief Summary | The aim of this clinical trial is to evaluate the antitussive effect of "Theobromine capsule 300mg" in patients with acute bronchitis. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||||||||||||||||||||||||||
| Study Phase | Phase 3 | ||||||||||||||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Acute Bronchitis | ||||||||||||||||||||||||||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||||||||||||||||||
| Enrollment ICMJE | 332 | ||||||||||||||||||||||||||||||||
| Completion Date | May 2011 | ||||||||||||||||||||||||||||||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
patient who will continue to cough more than 1 week.(by physician's judgment) Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||||||||||
| Location Countries ICMJE | Korea, Republic of | ||||||||||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||||||||||
| NCT Number ICMJE | NCT01416480 | ||||||||||||||||||||||||||||||||
| Other Study ID Numbers ICMJE | AG1321001_ACP3 | ||||||||||||||||||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||||||||||||||||||
| Responsible Party | Jung Hoon, Han / Senior Researcher, Project Development Team / Ahn-Gook Pharmaceuticals Co.,Ltd | ||||||||||||||||||||||||||||||||
| Study Sponsor ICMJE | Ahn-Gook Pharmaceuticals Co.,Ltd | ||||||||||||||||||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Ahn-Gook Pharmaceuticals Co.,Ltd | ||||||||||||||||||||||||||||||||
| Verification Date | August 2011 | ||||||||||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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