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

August 12, 2011 updated by: Ahn-Gook Pharmaceuticals Co.,Ltd

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

332

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Anyang, Gyeonggi-do, Korea, Republic of, 431-070
        • Hallym University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cough remission rate
Time Frame: 3 days
cough remission : no cough or 1 short cough in day time
3 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 Ilsan Paik Hospital
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

August 12, 2011

First Submitted That Met QC Criteria

August 12, 2011

First Posted (Estimate)

August 15, 2011

Study Record Updates

Last Update Posted (Estimate)

August 15, 2011

Last Update Submitted That Met QC Criteria

August 12, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG1321001_ACP3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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