UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005479 |
|---|---|
| Receipt number | R000006499 |
| Scientific Title | A study on efficacy of Pregabalin for the cervical dissection postoperative pain |
| Date of disclosure of the study information | 2011/04/25 |
| Last modified on | 2011/04/21 15:52:01 |
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Basic information
Public title
A study on efficacy of Pregabalin for the cervical dissection postoperative pain
Acronym
cervical dissection postoperative pain
Scientific Title
A study on efficacy of Pregabalin for the cervical dissection postoperative pain
Scientific Title:Acronym
cervical dissection postoperative pain
Region
| Japan |
Condition
Condition
cervical dissection postoperative pain
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine efficacy of pregabalin for the cervical dissection postoperative pain
Basic objectives2
Others
Basic objectives -Others
the efficacy of pregabalin for the tinnitus.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Subjective improvement (VAS level) with pregabalin of the cervical dissection postoperative pain
Key secondary outcomes
After improvement (PDAS score) of the quality of life with the pregabalin administration, neck dissection a change of the quality of life using the questionnaire (a simple version), improvement (a VAS level, THI, an examination for standard tinnitus) of the tinnitus with the pregabalin administration
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
pregabalin
Interventions/Control_2
NSAIDS,Fomentation,and othors
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
After cervical dissection enforcement, pass more than 30 days; the patients with the pain after the cervical dissection
Key exclusion criteria
(1) the patients with a history of hypersensitivity for an ingredient of pregabalin.
(2) A pregnant woman, woman in childbed, nursing mother.
(3) The serum creatinine level is the patients more than 0.9 mg/dl.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoo Onoda |
Organization
Okayama University Hospital
Division name
Department of Otolaryngology-Head and Neck surgery
Zip code
Address
2-5-1, Shikatacho, Kita-ku, Okayama-city
TEL
0862357307
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoo Onoda |
Organization
Okayama University Hospital
Division name
Department of Otolaryngology-Head and Neck surgery
Zip code
Address
2-5-1, Shikatacho, Kita-ku, Okayama-city
TEL
0862357307
Homepage URL
Sponsor or person
Institute
Okayama University Hospital,Department of Otolaryngology-Head and Neck surgery
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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
岡山大学病院 耳鼻咽喉・頭頸部外科
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 25 | 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 | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 21 | Day |
Last modified on
| 2011 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006499
