UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000041038
Receipt No. R000043832
Scientific Title Examination of the feeling of taking for improvement of medication adherence of clarithromycin dry syrup in pediatric patients
Date of disclosure of the study information 2020/07/09
Last modified on 2020/07/09 (Ver. 1)

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Basic information
Public title Examination of the feeling of taking for improvement of medication adherence of clarithromycin dry syrup in pediatric patients
Acronym Examination of the feeling of taking for improvement of medication adherence of clarithromycin dry syrup in pediatric patients
Scientific Title Examination of the feeling of taking for improvement of medication adherence of clarithromycin dry syrup in pediatric patients
Scientific Title:Acronym Examination of the feeling of taking for improvement of medication adherence of clarithromycin dry syrup in pediatric patients
Region
Japan

Condition
Condition Respiratory disease
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the feeling of taking antibiotics of generic and generic products in pediatric patients and investigate the effect on medication adherence.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Medication adherence
Key secondary outcomes Feeling of taking (ease of drinking, facial expression, ease of melting, smell, sweetness, bitterness)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are 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 A simple randomized cross-over study was conducted using two drugs, one that had been adopted in the past (brand name A) and the other that had been adopted after the taste test (brand name B), and each drug was taken twice a day for two days.
Interventions/Control_2 At the end of each dose, sweetness, bitterness, odor, solubility (index I-IV), and ease of taking the drug were assessed in five levels, and ease of taking were analyzed by multiple regression analysis with ease of taking as the objective variable.
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
3 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria Patients 3 years of age or older who were seen in our pediatric outpatient clinic between April 1, 2018 and March 31, 2020, and for whom CAM-DS was prescribed and who are considered to have a taste complaint.
Key exclusion criteria Patients who are unable to take their medication or for whom parental consent could not be obtained
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tomona
Middle name
Last name Sogo
Organization Mitoyo General Hospital
Division name Pharmaceutical department
Zip code 769-1695
Address 708 Himehama,Toyohama-cho,Kan-onji-city,Kagawa,JAPAN
TEL 0875-52-3366
Email shino-ph@mitoyo-hosp.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Shinonaga
Organization Mitoyo General Hospital
Division name Pharmaceutical department
Zip code 769-1695
Address 708 Himehama,Toyohama-cho,Kan-onji-city,Kagawa,JAPAN
TEL 0875-52-3366
Homepage URL
Email shino-ph@mitoyo-hosp.jp

Sponsor
Institute Mitoyo General Hospital
Pharmaceutical department
Institute
Department

Funding Source
Organization Mitoyo General Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Research Review Committee of Mitoyo General Hospital
Address 708 Himehama,Toyohama-cho,Kan-onji-city,Kagawa,JAPAN
Tel 0875-52-3366
Email shino-ph@mitoyo-hosp.jp

Secondary IDs
Secondary IDs YES
Study ID_1 17CR01-057
Org. issuing International ID_1 Clinical Research Review Committee of Mitoyo General Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 三豊総合病院（香川県）

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 09 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 19
Results 
The mean dosing status score for brand name A was 18.1 and for generic B was 19.3. Multiple regression analysis revealed that the standard regression coefficients for the original drug A were I - 0.34, II 0.51, III 0.47, and IV 0. 26. (All NS) For generic B, the coefficients were I-0.07, II-1.08, III-0.42, and IV-0.28. (NS for I, p<0.01 for II and III, and p<0.05 for IV) The mean score for ease of drinking was A2 for the branded drug. .26 and generic B3.05.
Results date posted
2020 Year 07 Month 09 Day
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
2018 Year 02 Month 26 Day
Date of IRB
2018 Year 02 Month 27 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 06 Month 30 Day
Date trial data considered complete
2020 Year 06 Month 30 Day
Date analysis concluded
2020 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2020 Year 07 Month 09 Day
Last modified on
2020 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043832