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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012364
Receipt No. R000014456
Scientific Title Drug registry study to evaluate the effectiveness of tramadol / acetaminophen combination tablets as pain management for patient with rheumatoid arthritis.
Date of disclosure of the study information 2013/11/25
Last modified on 2015/05/20

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Basic information
Public title Drug registry study to evaluate the effectiveness of tramadol / acetaminophen combination tablets as pain management for patient with rheumatoid arthritis.
Acronym Research for an appropriate use of tramadol / acetaminophen combination tablets for patient with rheumatoid arthritis.
Scientific Title Drug registry study to evaluate the effectiveness of tramadol / acetaminophen combination tablets as pain management for patient with rheumatoid arthritis.
Scientific Title:Acronym Research for an appropriate use of tramadol / acetaminophen combination tablets for patient with rheumatoid arthritis.
Region
Japan

Condition
Condition rheumatoid arthritis
Classification by specialty
Clinical immunology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness of tramadol / acetaminophen combination tablets as pain management for patient with rheumatoid arthritis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Mean change from baseline of Visual Analogue Scale (VAS)
Key secondary outcomes 1.Pain assessment: Mean value of Visual Analogue Scale(VAS), Mean change ratio from baseline of Visual Analogue Scale(VAS)
2. Disease activity assessment: Mean value of DAS28 and SDAI, Mean change and change ratio from baseline of DAS28 and SDAI.
3. Patients reported outcome: Mean value of MHAQ and EQ-5D, Mean change and change ratio from baseline of MHAQ and EQ-5D.
4. Quality of sleep: Mean value of Visual Analogue Scale(VAS), Mean change ratio from baseline of Visual Analogue Scale(VAS)
5. Opioid related adverse event
6. Treatment status: Treatment discontinuation rate.

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 / acetaminophen combination tablets will be administrated by 1 tablets / time/ qid and every 4 hours for pain relief.
Step by step dose up administration schedule over 4weeks will be applied at beginning of treatment as bellows;
*Day1-Day7(1 tablet/day, after night meal)
*Day8-Day14(1 tabletX2 times /day, after morning and night meal)
*Day15-Day21(1 tabletX3 times /day, after morning, afternoon and night meal
*Day22-Day30(1 tabletX4 times /day, after morning, night meal and before bedtime)
Once dose reached to 1 tabletX4 times /day, then treatment will be continue up to 24 weeks.
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
25 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria *Rheumatoid arthritis (RA)
*Duration of RA > = 6 months
*Patient who are recieving standard RA treatment
*Visual analogue scale >= 10 mm at baseline
*Patient who shows insufficient pain relief to non-opioid analgesic treatment or who does not meet to use non-opioid analgesic.
*Steinbrocker functional category = < III (because of clinical outcome evaluation in case of Steinbrocker functional category IV)
Key exclusion criteria *Patient who received surgery within 3 months
*Patient who have history of bone fracture (including non-traumatic fracture).
*Patient who had a significant unstable RA disease status.
*Patients who is addiction for alcohol, narcoleptic agents, opioids and psychotropic agents)
*Patient who is taking MAO inhibitors or discontinue MAO inhibitors within 14 days
*Patient who had a history of seizures
*Patient who had peptic ulcer
*Patient who had severe hematological disorder
*Patient who had a severe liver function disorder
*Patient who had a severe renal function disorder
*Patient who had a severe respiratory disorder.
*Patient who had a history of aspirin asthma
*Patient who had a history of hypersensitivity for tramadol or acetaminophen
*Patient who is taking Selegiline
*Patient who had a history of treatment by opioids within 3 months
*Patient who was pregnant, planning on becoming pregnant or breast feeding
Target sample size 31

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Tada
Organization Osaka City University Medical School
Division name Department of Orthopedic Surgery
Zip code
Address 1-4-3 Asahimachi, Abeno-ku, Osaka
TEL 06-6645-3851
Email m-tada@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Tada
Organization Osaka City University Medical School
Division name Department of Orthopedic Surgery
Zip code
Address 1-4-3 Asahimachi, Abeno-ku, Osaka
TEL 06-6645-3851
Homepage URL
Email m-tada@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Medical School, Department of Orthopedic Surgery
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
2013 Year 11 Month 25 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
2013 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 10 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
2013 Year 11 Month 20 Day
Last modified on
2015 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014456

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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