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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01416480
Recruitment Status : Completed
First Posted : August 15, 2011
Last Update Posted : August 15, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Acute Bronchitis Drug: Theobromine 300mg Drug: Levodropropizine 10mg Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 332 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : May 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Theobromine

Arm Intervention/treatment
Experimental: Theobromine
Theobromine capsule 300mg
Drug: Theobromine 300mg
Capsule, b.i.d.

Active Comparator: levodropropizine
levodropropizine syrup
Drug: Levodropropizine 10mg
Syrup, t.i.d.

Primary Outcome Measures :
  1. cough remission rate [ Time Frame: 3 days ]
    cough remission : no cough or 1 short cough in day time

Secondary Outcome Measures :
  1. cough recovery rate [ Time Frame: 1 day, 2 days, within 3days ]
  2. difference of DCS score between screening and closing visit. [ Time Frame: 3 days ]
  3. required time for cough remission [ Time Frame: 3 days ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01416480

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Korea, Republic of
Hallym University Medical Center
Anyang, Gyeonggi-do, Korea, Republic of, 431-070
Sponsors and Collaborators
Ahn-Gook Pharmaceuticals Co.,Ltd
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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 Hospital
Principal Investigator: Jung Hyun chang, M.D. Ewha Womans University Mokdong Hospital
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Responsible Party: Jung Hoon, Han / Senior Researcher, Project Development Team / Ahn-Gook Pharmaceuticals Co.,Ltd Identifier: NCT01416480    
Other Study ID Numbers: AG1321001_ACP3
First Posted: August 15, 2011    Key Record Dates
Last Update Posted: August 15, 2011
Last Verified: August 2011
Keywords provided by Ahn-Gook Pharmaceuticals Co.,Ltd:
acute bronchitis
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Vasodilator Agents
Antitussive Agents