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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

August 12, 2011
August 12, 2011
May 2010
February 2011   (final data collection date for primary outcome measure)
cough remission rate [ Time Frame: 3 days ] [ Designated as safety issue: No ]
cough remission : no cough or 1 short cough in day time
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Clinical Trial to Evaluate the Safety and Efficacy of "Theobromine Capsule" as an Antitussive in Acute Cougher
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Theobromine Capsule 300mg" as an Antitussive Agent in Acute Cough Patients.

The aim of this clinical trial is to evaluate the antitussive effect of "Theobromine capsule 300mg" in patients with acute bronchitis.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Bronchitis
  • Drug: Theobromine 300mg
    Capsule, b.i.d.
  • Drug: Levodropropizine 10mg
    Syrup, t.i.d.
  • Experimental: Theobromine
    Theobromine capsule 300mg
    Intervention: Drug: Theobromine 300mg
  • Active Comparator: levodropropizine
    levodropropizine syrup
    Intervention: Drug: Levodropropizine 10mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
332
May 2011
February 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01416480
AG1321001_ACP3
Yes
Jung Hoon, Han / Senior Researcher, Project Development Team / Ahn-Gook Pharmaceuticals Co.,Ltd
Ahn-Gook Pharmaceuticals Co.,Ltd
Not Provided
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
Ahn-Gook Pharmaceuticals Co.,Ltd
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP