Drug registry study to evaluate the effectiveness of tramadol / acetaminophen combination tablets as pain management for patient with rheumatoid arthritis.

Not Applicable

• Conditions: rheumatoid arthritis

• Registration Number: JPRN-UMIN000012364
• Lead Sponsor: Osaka City University Medical School, Department of Orthopedic Surgery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change from baseline of Visual Analogue Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
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.