UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017510
Receipt No. R000020266
Scientific Title Usefulness and safety of Tramadol Hydrochloride Acetaminophen Combination Table in musculoskeletal system with chronic pain,a prospective and multicenter study
Date of disclosure of the study information 2015/05/11
Last modified on 2015/05/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Usefulness and safety of Tramadol Hydrochloride Acetaminophen
Combination Table in musculoskeletal system with chronic pain,a prospective and multicenter study
Acronym Usefulness of Tramadol Hydrochloride Acetaminophen Combination Tablet
Scientific Title Usefulness and safety of Tramadol Hydrochloride Acetaminophen
Combination Table in musculoskeletal system with chronic pain,a prospective and multicenter study
Scientific Title:Acronym Usefulness of Tramadol Hydrochloride Acetaminophen Combination Tablet
Region
Japan

Condition
Condition musculoskeletal system with chronic pain
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy and safety of Tramadol Hydrochloride Acetaminophen Combination Tablet
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Numeric Rating Scale
EQ-5D
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Tramadol Hydrochloride Acetaminophen Combination Tablet
Interventions/Control_2
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 Subjects with symptomatic patients who experienced at least moderate pain (NRS score is at least 4) despite treatment with non-steroidal anti-inflammatory drugs
Key exclusion criteria Exclusion criteria included a history of alcohol or drug abuse; or any known allergy, sensitivity, or contraindication to a study medication
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiji Ohtori
Organization Graduate school of medicine,
Chiba University
Division name Department of Orthopaedic Surgery
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba
TEL 043-222-7171
Email sohtri@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seiji Ohtori
Organization Graduate school of medicine,
Division name Department of Orthopaedic Surgery
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba
TEL 043-222-7171
Homepage URL
Email sohtri@faculty.chiba-u.jp

Sponsor
Institute Department of Orthopeadic Surgery ,
Graduate school of medicine,
Chiba University
Institute
Department

Funding Source
Organization Department of Orthopeadic Surgery ,
Graduate school of medicine,
Chiba University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

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
2015 Year 05 Month 11 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
2012 Year 06 Month 27 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 11 Day
Last modified on
2015 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020266

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.