UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020558 |
|---|---|
| Receipt number | R000023733 |
| Scientific Title | Efficacy of pregabalin for post-operative pain in patients with soft tissue sarcoma arising in lower extremities. |
| Date of disclosure of the study information | 2016/01/14 |
| Last modified on | 2017/08/25 07:55:34 |
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Basic information
Public title
Efficacy of pregabalin for post-operative pain in patients with soft tissue sarcoma arising in lower extremities.
Acronym
Efficacy of pregabalin for post-operative pain for lower exterimity soft tissue sarcoma
Scientific Title
Efficacy of pregabalin for post-operative pain in patients with soft tissue sarcoma arising in lower extremities.
Scientific Title:Acronym
Efficacy of pregabalin for post-operative pain for lower exterimity soft tissue sarcoma
Region
| Japan |
Condition
Condition
soft tissue sarcoma
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate pregabalin for post-operative pain in patients with soft tissue sarcoma of lower extremity
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
pain VAS at 2 weeks after surgery
Key secondary outcomes
pain VAS at 4 weeks after surgery
sleep VAS at 1, 2, and 4 weeks after surgery
painDETECT at 1, 2, 4 weeks after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
pregabalin(75mgx2/day)+Lorcam(4mgx3/day)
from day3 after surgery to 14 days after surgery
Interventions/Control_2
Lorcam(4mgx3/day)
from day3 after surgery to 14 days after surgery
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
patients with soft tissue sarcoma of lower extermity, who require surgical treatment
Key exclusion criteria
patients with renal dysfunction, gastric ulcer, pregnancy, heart disease
patients who was considered inadequate by a physician in charge
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Nishida |
Organization
Nagoya University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
65-Tsurumai, Showa, Nagoya
TEL
052-741-2111
ynishida@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Nishida |
Organization
Nagoya University Graduate School of Medicine
Division name
Orthopaedic Surgery
Zip code
Address
65-Tsurumai, Showa, Nagoya
TEL
052-741-2111
Homepage URL
ynishida@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
self-funding
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
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
| 2016 | Year | 01 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2013 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 13 | Day |
Last modified on
| 2017 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023733
