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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020558
Receipt No. 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

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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
Email 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
Email ynishida@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023733

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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