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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022237
Receipt No. 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

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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
Condition after anterior cruciate ligament reconstruction
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

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 3
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 90

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

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
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 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
URL(English) https://upload.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


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