UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041038 |
|---|---|
| Receipt number | 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 09:43:27 |
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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
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
shino-ph@mitoyo-hosp.jp
Sponsor or person
Institute
Mitoyo General Hospital
Pharmaceutical department
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043832
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