UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012364 |
|---|---|
| Receipt number | 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 10:58:45 |
* 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
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
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
m-tada@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Medical School, Department of Orthopedic Surgery
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
| 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
Value
https://center6.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 |
