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

This study has been completed.
Sponsor:
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
  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:


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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Mokdong Hospital
  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 July 20, 2014