UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015564 |
|---|---|
| Receipt number | R000018083 |
| Scientific Title | Study assessing combined therapy with clarithromycin and amoxicillin in childhood acute otitis media |
| Date of disclosure of the study information | 2014/11/01 |
| Last modified on | 2015/10/27 10:14:24 |
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Basic information
Public title
Study assessing combined therapy with clarithromycin and amoxicillin in childhood acute otitis media
Acronym
Study assessing combined therapy with clarithromycin and amoxicillin in childhood acute otitis media
Scientific Title
Study assessing combined therapy with clarithromycin and amoxicillin in childhood acute otitis media
Scientific Title:Acronym
Study assessing combined therapy with clarithromycin and amoxicillin in childhood acute otitis media
Region
| Japan |
Condition
Condition
Pediatric patients with childhood acute otitis media determined to be of moderate severity in accordance with the Clinical Practice Guideline for Diagnosis and Management of Acute Otitis Media in Children (2013, hereinafter referred to as the Guideline).
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the efficacy and safety of treatment with amoxicillin alone or in combination with clarithromycin in pediatric patients with moderate childhood acute otitis media
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Efficacy evaluation (scoring for the severity of acute otitis media)
The endpoints are the percentages of patients who show a complete response or partial response and patients who show a complete response, partial response or no change among all patients for efficacy evaluation. For the percentages, 95% confidence intervals will be calculated. The percentage of patients who show a complete response or partial response among all patients for efficacy evaluation will be compared between the AMPC group and CAM/AMPC group using Fisher's exact test.
(2) Lift reflex
Summary statistics for scores and changes in scores from the start of study treatment until the completion or discontinuation of study treatment will be calculated at designated time points and compared between the AMPC group and CAM/AMPC group using the Wilcoxon rank sum test.
(3) Safety evaluation
The numbers of events, numbers of patients who experience events, frequencies and corresponding 95% confidence intervals will be calculated for all adverse events and adverse events for which the causal relationship to the investigational drug cannot be ruled out. The frequencies of adverse events and events for which the causal relationship to the investigational drug cannot be ruled out will be compared between the AMPC group and CAM/AMPC group using Fisher's exact test. The level of significance is 0.05 for a two-sided test.
Key secondary outcomes
(1)Efficacy evaluation (by the physician)
The endpoints are the percentages of patients who show a complete response or partial response and those who show a complete response, partial response, slight response or no change among all patients for efficacy evaluation. Analyses will be performed using the analysis procedures for primary endpoint (1).
(2) Test of cure
The endpoints are the percentages of patients who are cured and patients who are cured or are not cured among all patients for efficacy evaluation. Analyses will be performed using the analysis procedures for primary endpoint (1).
(3) Evaluation of exacerbation of infection
The endpoints are the percentages of patients who do not experience exacerbation of infection and patients who experience or do not experience exacerbation of infection among all patients for efficacy evaluation. Analyses will be performed using the analysis procedures for primary endpoint (1).
(4) Bacteriological efficacy
The endpoints are the percentage of patients for whom bacterial infection has resolved, appears to have resolved or has partially resolved and the percentage of patients for whom bacterial infection has resolved, appears to have resolved, has partially resolved or has not changed among all patients for efficacy evaluation. Analyses will be performed using the analysis procedures for primary endpoint (1).
(5) Background factors causing acute otitis media to become refractory
For the following, the odds ratios and corresponding 95% confidence intervals will be calculated: young children under 2 years old; detection of drug-resistant bacteria; history of recurrence of otitis media; group childcare; history of treatment with antimicrobial drugs during the previous month; onset of complication of sinusitis; and onset of bilateral diseases.
(6) Follow-up
The time to exacerbation and number of times exacerbations occur will be summarized.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention group (clarithromycin/amoxicillin group): amoxicillin is administered for 5 days, and clarithromycin for 3 days.
Interventions/Control_2
Control group: amoxicillin is administered for 5 days
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 0 | years-old | <= |
Age-upper limit
| 5 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients between 28 days and 5 years old at the time informed consent is obtained
(2) Patients determined to have moderate severity acute otitis media in accordance with the Guideline
(3) Patients for whom written informed consent can be obtained from the guardian of the patient
Key exclusion criteria
(1) Patients with a history of hypersensitivity to penicillin-based or macrolide-based antibiotics
(2) Patients with a history of epilepsy or other convulsive disorders
(3) Immunodeficient patients
(4) Patients with maxillofacial growth impairment
(5) Patients determined by the investigator or sub-investigator as ineligible for the present study
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihisa Togawa |
Organization
Wakayama Medical University
Division name
otolaryngology, head and neck surgery
Zip code
Address
811-1, Kimiidera, Wakayama-shi, Wakayama
TEL
073-441-0651
togawa@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Study secretariat |
Organization
Satt Co., Ltd
Division name
Promotion group
Zip code
Address
Urbanprem Shinjuku 5F, 2-12-8 Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-5312-5026
Homepage URL
otitis@sa-tt.co.jp
Sponsor or person
Institute
Wakayama Medical University otolaryngology, head and neck surgery
Institute
Department
Personal name
Funding Source
Organization
Taisho Toyama pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 30 | Day |
Last modified on
| 2015 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018083
