UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015564
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Last 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
Email togawa@wakayama-med.ac.jp

Public contact
1st 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
Email otitis@sa-tt.co.jp

Sponsor
Institute Wakayama Medical University otolaryngology, head and neck surgery
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018083

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.