Axial Spondyloarthritis
Conditions
Interventions
Trade Name: Ibumetin 400 mg
Product Name: Ibumetin 400 mg
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
University of Tromsø
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Pasients must have been diagnosed with radiographic Axial Spondyloarthritis, also called Ankyloserende Spondylitis, OR •Pasients must have been diagnosed with non-radiografic Axial Spondyloarthritis with a positive magnetic resonance (MR). •Patients must have been successfully treated with NSAIDs for at least three months •Patients must be above 20 years old •Patients must satisfy the Norwegian Summary of Product Characteristics (SPC) for Ibumetin 400 mg Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Patients cannot participate in other clinical studies parallel to the current study. Previous study participations must be completed more than one year, prior to participating in the current study. •Patients not satisfying the Norwegian Summary of Product Characteristics (SPC) for Ibumetin 400 mg: •Patients who previously have experienced allergic reactions to NSAIDs •Patients with previous or currant ulcers and/or gastrointestinal conditions - or bleeding •Patients with previous or currant cardiovascular conditions, or have experienced cardiovascular episodes •Patients with previous or currant renal failure •Patients with acetaminophen - or NSAID-induced asthma, urticarial or rhinitt •Patients with previous or current other serious conditions apart from rheumatoid arthritis •Female patients trying to or having trouble getting pregnant cannot participate in the study •Pregnant and/or nursing patients cannot participate in the study •Patients on a treatment plan with Prednisolon •Patients on a treatment plan with substances inflicting with Ibumetin. All substances will be investigated on www.interaksjoner.no
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the generation, magnitude and duration of the placebo analgesic response in the natural environment of patients with chronic pain.;Secondary Objective: Investigate how information about the treatment influence the analgesic effect.;Primary end point(s): Pain;Timepoint(s) of evaluation of this end point: 09:00, 09:10, 11:00, 13:00, 15:00, 17:00 and 19:00 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Stress;Timepoint(s) of evaluation of this end point: Same as the timepoints above | — |
Countries
Norway
Contacts
Public ContactDepartment of Psychology
University of Tromsø
Outcome results
None listed