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