UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of tramadol- acetaminophen combination tablets for lumbar canal stenosis
Title of the study (Brief title)	Efficacy and safety of tramadol- acetaminophen combination tablets for lumbar canal stenosis
Region	Japan

Condition
Condition	lumbar canal stenosis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the efficacy of tramadol- acetaminophen combination tablets for the pain of the patient with lumbar canal stenosis
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	QOL associated with lumbar back pain and intermittent claudication
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	6 weeks oral administration of tramadol / acetaminophen combination tablets
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patient who have continious pain or numbness due to lumbar canal steosis The patient who has intermittent caludication (less than 30 minutes or 2 km)
Key exclusion criteria	The patient who have serious disorder The patient who have malignant tumor The patient who have mental disease
Target sample size	30

Research contact person
Name of lead principal investigator	Morio Matsumoto
Organization	Keio University School of Medicine
Division name	Department of Orthopaedic Surgery
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	morio@a5.keio.jp

Public contact
Name of contact person	Nobuyuki Fujita
Organization	Keio University School of Medicine
Division name	Department of Orthopaedic Surgery
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL
Email	nfujita2007@yahoo.co.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Keio University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 10 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 05 Month 28 Day
Anticipated trial start date	2012 Year 11 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 28 Day
Last modified on	2016 Year 04 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025501