rheumatoid arthritis
Conditions
Interventions
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
*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(
Sponsors
Osaka City University Medical School, Department of Orthopedic Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline of Visual Analogue Scale (VAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactMasahiro Tada
Osaka City University Medical School Department of Orthopedic Surgery
Outcome results
None listed