UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007214 |
|---|---|
| Receipt number | R000008491 |
| Scientific Title | Effect of carbocisteine on nasal discharge and post nasal discharge in patients with acute rhinosinusitis after antibiotic treatment |
| Date of disclosure of the study information | 2012/09/30 |
| Last modified on | 2012/02/02 16:48:18 |
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Basic information
Public title
Effect of carbocisteine on nasal discharge and post nasal discharge in patients with acute rhinosinusitis after antibiotic treatment
Acronym
Effect of carbocisteine on nasal discharge and post nasal discharge in patients with acute rhinosinusitis after antibiotic treatment
Scientific Title
Effect of carbocisteine on nasal discharge and post nasal discharge in patients with acute rhinosinusitis after antibiotic treatment
Scientific Title:Acronym
Effect of carbocisteine on nasal discharge and post nasal discharge in patients with acute rhinosinusitis after antibiotic treatment
Region
| Japan |
Condition
Condition
Acute rhinosinusitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of carbocisteine on residual nasal symptoms (nasal discharge, post nasal discharge) in patients with acute rhinosinusitis after antibiotic treatment
1) To evaluate the change in scores of scoring system for assessing the clinical severity of acute rhinosinusitis
2)To evaluate the change in daily report of symptoms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Change in scores of scoring system for assessing the clinical severity of acute rhinosinusitis
To measure the change in scores within the group between day 10 to 14 (day 5 to 7)
To measure the score (rate of change) between the groups between day 10 to 14 (day 5 to 7)
2.Change in total score of 8 items in daily report
To measure the hange in scores within the group
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Only as for the same antimicrobial
Interventions/Control_2
Same antimicrobial and Carbocisteine (1,500 mg/ day) 3 times/ day
Interventions/Control_3
Only as for the antimicrobial which I changed
Interventions/Control_4
Only as for the antimicrobial which I changed and Carbocisteine (1,500 mg/ day) 3 times/ day
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patient with acute rhinosinusitis
2.Patient who are 20 years old or older at the time of giving informed consent
3.Patients who are classified as mild and do not show improvement in 5 days or classified as moderate or more in severity assessment in the clinical guideline for acute rhinosinusitis
4.Patients with the score 1 or more in the nasal findings in the scoring system for acute rhinosinusitis in 5 days after the administration of antibiotics
5.Patients giving written informed consent to this study
Key exclusion criteria
1.Patients who cannot tolerate carbocisteine
2.Patients who received airway disease drugs (mucolytic agents) within 10 days to the start of this study
3.Patients who were scheduled to later receive airway disease drugs at the start of this study
4.Patients participating in other studies at the start of this study
5.Patients with history of severe hepatic diseases, renal diseases, cardiovascular diseases, or other cormobidities
6.Patients with a complication of malignant tumors
7.Women who are not pregnant or lactating, and not expecting future pregnancy
8.Patients who are judged inappropriate by physicians in charge
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikeda Yorihiko |
Organization
Wakayama Medical University
Division name
Otolaryngology-Head and Neck Surgery
Zip code
Address
811-1 Kimiidera, Wakayama-shi, Wakayama 641-8509, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Wakayama-Okayama Otolaryngology Pharma
Division name
secretariat
Zip code
Address
TEL
Homepage URL
woop@calo.co.jp
Sponsor or person
Institute
Wakayama-Okayama Otolaryngology Pharma
Institute
Department
Personal name
Funding Source
Organization
Wakayama-Okayama Otolaryngology Pharma
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2012 | Year | 09 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 02 | Day |
Last modified on
| 2012 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008491
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| Registered date | File name |
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| Registered date | File name |
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