UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000022237
Receipt number	R000016279
Scientific Title	Single-drug and combined medication with lornoxicam and pregabal after anterior cruciate ligament reconstruction
Date of disclosure of the study information	2016/05/09
Last modified on	2016/05/27 00:50:18

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Basic information

Public title

Single-drug and combined medication with lornoxicam and pregabal after anterior cruciate ligament reconstruction

Acronym

Single-drug and combined medication with lornoxicam and pregabal after anterior cruciate ligament reconstruction

Scientific Title

Single-drug and combined medication with lornoxicam and pregabal after anterior cruciate ligament reconstruction

Scientific Title:Acronym

Single-drug and combined medication with lornoxicam and pregabal after anterior cruciate ligament reconstruction

Region

Japan

Condition

after anterior cruciate ligament reconstruction

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

The poupose of this project is to evaluate the efficacy of single-drug and combined medication with lornoxicam and pregabalin for anterior cruciate ligament reconstruction patients

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Assessment

Primary outcomes

pain (visual analogue scale) within two weeks after surgery
neuropathic pain at 3 and 6 months after surgery

Key secondary outcomes

range of motion of the knee and muscle strength (active straight leg raise) at 1 weeks after surgery

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Lornoxicam group (group L)
Lornoxicam (Lorcam 4mg tablet, Taisho-toyama, Japan) 24mg/day for the first 3 postoperative days (taken in 8mg at the day of surgery), and then 12mg/day until 14 post-operative days.

Interventions/Control_2

Pregabalin group (group P)
Pregabalin (Lyrica 75mg capsule, Pfizer, Japan) 75mg was given orally at the day of surgery, then pregabalin was taken in 150mg/day until 14 postoperative days.

Interventions/Control_3

Lornoxicam plus pregabalin group
Lornoxicam (Lorcam 4mg tablet, Taisho-toyama, Japan) 24mg/day for the first 3 postoperative days (taken in 8mg at the day of surgery), and then 12mg/day until 14 post-operative days.
Pregabalin (Lyrica 75mg capsule, Pfizer, Japan) 75mg was given orally at the day of surgery, then pregabalin was taken in 150mg/day until 14 postoperative days.

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

15 years-old <=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who had undergone primary and revision ACL reconstruction at our institution.

Key exclusion criteria

Patients were excluded if they were younger than 15, had a history of renal or liver failure, pregnant woman , or had a history of allergy to any of the study medications.

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Shugo Maeda

Organization

Hirosaki University School of Medicine & Hospital

Division name

Department of Orthopaedic surgery

Zip code

Address

53 Hon-cho, Hirosaki, Aomori

TEL

0172-33-5111

Email

maechin@ta3.so-net.ne.jp

Public contact

Name of contact person

1st name

Middle name

Last name Shugo Maeda

Organization

Hirosaki University School of Medicine & Hospital

Division name

Department of Orthopaedic Surgery

Zip code

Address

53 Hon-cho, Hirosaki, Aomori

TEL

0172-33-5111

Homepage URL

Email

maechin@ta3.so-net.ne.jp

Sponsor or person

Institute

Department of Orthopaedic Surgery, Hirosaki University School of Medicine & Hospital

Institute

Department

Personal name

Funding Source

Organization

none

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 09 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

Completed

Date of protocol fixation

2012 Year 09 Month 18 Day

Date of IRB

Anticipated trial start date

2012 Year 11 Month 01 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

2014 Year 03 Month 31 Day

Date analysis concluded

2016 Year 05 Month 08 Day

Other

Other related information

Management information

Registered date

2016 Year 05 Month 08 Day

Last modified on

2016 Year 05 Month 27 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016279

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name