se of placebo in treatment of Axial Spondyloarthritis

• Conditions: Axial Spondyloarthritis; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2013-000098-65-NO
• Lead Sponsor: niversity of Tromsø

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-21
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Stress;Timepoint(s) of evaluation of this end point: Same as the timepoints above