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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002525
Receipt No. R000003084
Scientific Title Efficacy of combined effect of Carbocisteine in chronic sinusitis patients taking Clarithromycin
Date of disclosure of the study information 2009/09/24
Last modified on 2009/11/24

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Basic information
Public title Efficacy of combined effect of
Carbocisteine in chronic sinusitis
patients taking Clarithromycin
Acronym GETS Study
Scientific Title Efficacy of combined effect of
Carbocisteine in chronic sinusitis
patients taking Clarithromycin
Scientific Title:Acronym GETS Study
Region
Japan

Condition
Condition Chronic Sinusitis
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To weigh the differences of clinical effect between carbocisteine 1500mg/day-
clarithromycin 200mg/day against
clarithromycin 200mg/day
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Clinical effect (after 12 weeks)
Key secondary outcomes 1. SNOT-20 improvement factor
2. CT scoring
3. Clinical effect(4 weeks, 8 weeks later)
4. Subjective symptoms
5. Objective symptoms

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Carbocisteine & Clarithromycin
Interventions/Control_2 Clarithromycin
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients with symptoms which had persisted for more than 12 weeks, such as nasal congestion, rhinorrhea, postnasal drip and coughing
2. Patients who were found to have paranasal sinus shadowing upon simple X-ray or CT conducted after the patient displayed one or more
of the symptoms in 1.
3. Patients who had at least one subjective symptom (nasal
discharge, rhinorrhea, postnasal
drip, nasal congestion, heaviness of head (headache), dysosmia) and at least one objective symptom (nasal mucosal redness, nasal mucosal swelling, nasal discharge, postnasal drip) at the baseline.
4. Patients with nasal polyp of score 0 or 1 in severity
5. Outpatients
6. Patients 20 years old or above when submitting informed consent
7. Patients with the ability to
understand the QOL question items
8. Patients giving written informed consent
Key exclusion criteria 1. Patients who cannot tolerate
carbocisteine or clarithromycin
2. Patients who received airway
disease drugs (e.g. mucolytic agents) or 14-membered macrolides within 2 weeks prior to the start of the study
3. Patients who at the start of the study were scheduled to later receive anti-inflammatory enzyme, steroids (oral, inhalation, injection, nasal spray), anti-allergic agents, or
Chinese herbal medicine
4. Patients participating in other studies at the start of this study
5. Patients who have undergone
radical sinus surgery
6. Patients who have undergone endoscopic sinus surgery within 12 weeks prior to the start of the study
7. Patients who have or are suspected to have paranasal mycosis
8. Patients with complications of bronchial asthma
9.Patients with history of severe cardiovascular disease
10. Patients with a complication of malignant tumor
11.Women who are or may be pregnant
12.Patients considered inappropriate by the physicians in charge
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Majima
Organization Ise Municipal General Hospital
Division name Department of Otorhinolaryngology
Zip code
Address 3038 kusube-cho, Ise-shi, Mie, 516-0014 Japan
TEL 0596-23-5111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Michiaki Ota
Organization Kyorin Pharmaceutical Co.,LTD
Division name P.L.C. Management Department
Zip code
Address 5, Kanda Surugadai 2-chome,
TEL 03-3293-3422
Homepage URL
Email michiaki.oota@mb.kyorin-pharm.co.jp

Sponsor
Institute GETS Study Group
Institute
Department

Funding Source
Organization Kyorin Pharmaceutical Co.,LTD
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2009 Year 09 Month 24 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
2008 Year 03 Month 25 Day
Date of IRB
Anticipated trial start date
2008 Year 05 Month 01 Day
Last follow-up date
2009 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
2009 Year 09 Month 18 Day
Last modified on
2009 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003084

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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