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

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 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


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

Value
https://center6.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