UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004110
Receipt No. R000004815
Scientific Title Therapy for tinnitus with carbogen (95% oxygen and 5% CO2) inhalation
Date of disclosure of the study information 2010/09/01
Last modified on 2010/09/01

* 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 Therapy for tinnitus with carbogen (95% oxygen and 5% CO2) inhalation
Acronym Therapy for tinnitus with carbogen (95% oxygen and 5% CO2) inhalation
Scientific Title Therapy for tinnitus with carbogen (95% oxygen and 5% CO2) inhalation
Scientific Title:Acronym Therapy for tinnitus with carbogen (95% oxygen and 5% CO2) inhalation
Region
Japan

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

Objectives
Narrative objectives1 The aim of the study is to investigate whether carbogen (95% oxygen and 5% CO2) inhalation is an effective thetapy for patients with chronic tinnitus.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The intention whose patients with chronic tinnitus would like to take carbogen (95% oxygen and 5% CO2) inhalation for tinnitus continuously.
Key secondary outcomes THI (tinnitus handicap inventory) is perfomed 2 weeks later, one month later, 2 months later, just before the restart of the therapy, 2 weeks later of the tharapy restarted, one month later of the therapy restarted.

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 YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Other
Interventions/Control_1 Stomin A (Nicotinamide/Papaverine Hydrochloride)
Interventions/Control_2 carbogen (5% CO2 and 95% oxygen)
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. Men and women over 20 years old
2. having inner ear symptoms such as hearing loss,tinnitus, aural fullness, and hyperacusis.
3. having unilateral or bilateral sensorineural (or mixed) hearing disturbance in a pure tone audiometry. 4. having tinnitus over 3 months worry it.
5. therapy for tinnitus has not been performed over one month before the admission.
Key exclusion criteria 1. tinnitus with conductive hearing loss and/or with no hearing loss.
2. acute or subacute period within 3 months when patients have had tinnitus and hearing disturbance.
3. patients who are not worry about tinnitus.
4. patients having atelectasis of the lung and/or chronic obstructive pulmonary disease or patients suspected with these.
5. Patients with drug allegry.
6. Pregnant or post-pregnant patients giving milk.
Target sample size 192

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidetaka Kumagami
Organization Nagasaki University
Division name Otolaryngology
Zip code
Address Sakamoto 1-7-1, Nagasaki
TEL 095-819-7349
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hidetaka Kumagami
Organization Nagasaki University
Division name Otolaryngology
Zip code
Address Sakamoto1-7-1, Nagasaki, Japan
TEL 095-819-7349
Homepage URL
Email

Sponsor
Institute Department of Otolaryngology, Nagsaki University
Institute
Department

Funding Source
Organization Department of otolaryngplogy, Nagasaki University
Organization
Division
Category of Funding Organization Self funding
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 長崎大学病院(長崎県)

Other administrative information
Date of disclosure of the study information
2010 Year 09 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 Enrolling by invitation
Date of protocol fixation
2010 Year 08 Month 03 Day
Date of IRB
Anticipated trial start date
2010 Year 09 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
2010 Year 08 Month 27 Day
Last modified on
2010 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004815

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.