Skip to main content
OpenTrials
Completed

NCT Number: NCT01416480

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hallym University Medical Center

Anyang-si, Gyeonggi-do, 431-070, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient who decided to participate in this clinical trial at his(her) own will and agreed in written letter of consent.
  • Adult aged over 18
  • Patient who has cough symptom caused by acute bronchitis
  • Patient who go to see the doctor for severe cough at his(her) own will
  • DCS score at screening vist sould be over 3.
  • 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

  • Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as Acute infectious Pulmonary Disease, Tuberculosis, asthma.
  • Chronic bronchitis including bronchial obstruction
  • Patient who has clinical history of sensitivity to Xanthine drug.
  • Patient who has Peptic Ulcer
  • 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.
  • Patient whose heart function is abnormal: including the case of showing abnormal EKG test value that is clinically significant.
  • patient who has convulsion or alcoholism.
  • Patient who has experience to have participated in other clinical trial within two months before starting the trial.
  • Pregnant woman, lactating woman.
  • Patient who thought to be cured within 3 days without any medicine.

Treatment and study plan

Theobromine 300mg

Drug

Capsule, b.i.d.

Levodropropizine 10mg

Drug

Syrup, t.i.d.

Primary outcomes

  1. cough remission rate

    Time frame: 3 days

    cough remission : no cough or 1 short cough in day time

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ahn-Gook Pharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Theobromine Capsule 300mg" as an Antitussive Agent in Acute Cough Patients.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 15, 2011
Registry last updated
Aug 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.