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Safety and Efficacy of KALOMIN™ Tab. in Patients With Acute Bronchitis

Sponsor
Korea United Pharm. Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02151734
Collaborator
(none)
242
Enrollment
2
Arms

Study Details

Study Description

Brief Summary

This is a multi-center, double-dummy, double-blind, randomized, active-controlled, parallel group phase 3 clinical trial to evaluate the efficacy and safety of KALOMIN™ Tab. in patients with acute bronchitis.

The aim of this clinical trial is to demonstrate that KALOMIN™ Tab. is clinically non-inferior to Umckamin syrup, as assessed by BSS(Bronchitis Severity Score), in the treatment of acute bronchitis after 7 days.

Condition or Disease Intervention/Treatment Phase
  • Drug: KALOMIN™ Tab.
  • Drug: Umckamin syrup
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
242 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: KALOMIN™ Tab.

KALOMIN™ Tab./Placebo to Umckamin syrup

Drug: KALOMIN™ Tab.
Active Comparator: Umckamin syrup

Umckamin syrup/Placebo to KALOMIN™ Tab.

Drug: Umckamin syrup

Outcome Measures

Primary Outcome Measures

  1. Total score of BSS(Bronchitis Severity Score) [7days]

Secondary Outcome Measures

  1. Individual symptom score of BSS [7days]

  2. reaction rate of treatment [7days]

  3. IMOS(Integrative Medicine Outcome Scale) [7days]

  4. IMPSS(Integrative Medicine Patient Satisfaction Scale) [7days]

  5. Adverse events, clinical laboratory examination, physical examination, etc. [7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Male or female patients aged 12-75 years old

  • A total score of BSS ≥ 5

  • The duration of symptoms had to be less than 14 days and no chronic pulmonary disease

  • Patients who voluntarily sign a written informed consent to participate in the trial

Exclusion Criteria:

  • Indication for antibiotic treatment(e.g. severe respiratory infection)

  • Allergic bronchial asthma

  • Tendency to bleed

  • Severe heart, renal, or liver diseases or decline of immune function

  • Chronic obstructive pulmonary disease

  • Known or supposed hypersensitivity to investigational medication

  • Treatment with antibiotics during the past 4 weeks prior to inclusion in the trial

  • Women during pregnancy or lactation period

  • Clinically significant abnormal values in the screening test(more than twice the upper limit of normal range for ALT, AST, BUN, and Serum Creatinine)

  • Participation in any other trial within 30 days prior to inclusion in the trial

  • Unsuitable patients for enrollment in the opinion of the investigator

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Korea United Pharm. Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Korea United Pharm. Inc.
ClinicalTrials.gov Identifier:
NCT02151734
Other Study ID Numbers:
  • KUP-KLM_301
First Posted:
May 30, 2014
Last Update Posted:
May 30, 2014
Last Verified:
May 1, 2014
Additional relevant MeSH terms:
Bronchitis

Study Results

No Results Posted as of May 30, 2014