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

NCT01416480 | Completed Phase 3 DMC

• 1 other identifier: AG1321001_ACP3
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Bronchitis

Keywords

Theobromine; cough; acute bronchitis

Outcome Measures

Primary Outcomes (1)

• cough remission rate

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

  3 days

Secondary Outcomes (3)

• cough recovery rate

  1 day, 2 days, within 3days

• difference of DCS score between screening and closing visit.

  3 days

• required time for cough remission

  3 days

Study Arms (2)

Theobromine

EXPERIMENTAL

Theobromine capsule 300mg

Drug: Theobromine 300mg

levodropropizine

ACTIVE COMPARATOR

levodropropizine syrup

Drug: Levodropropizine 10mg

Interventions

Theobromine 300mg DRUG

Capsule, b.i.d.

Theobromine

Levodropropizine 10mg DRUG

Syrup, t.i.d.

levodropropizine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ahn-Gook Pharmaceuticals Co.,Ltd: lead

Study Sites (1)

Hallym University Medical Center

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

Location

MeSH Terms

Conditions

Bronchitis; Cough

Interventions

Theobromine; dipropizine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 12, 2011
• First Posted: August 15, 2011
• Study Start: May 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: May 1, 2011
• Last Updated: August 15, 2011

Record last verified: 2011-08

Locations

KR (1)