Treatment of Axial Spondyloarthritis With Reduced Doses of NSAIDs

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The following study investigates the role of information/expectancies in the response to Ibumetin and placebo.

The study is a double-blind randomized controlled trial with crossover, within subjects repeated measurements. The symptoms are measured by questionnaires. 40 patients will be included in the study. The administrated drug is Ibumetin 400 mg.

The study does not require patients to meet in the clinic. Patients will be instructed in how to report pain, tension and nervousness via mobile phone (Checkware AS, Trondheim, Norway).Three days a week for 12 weeks the patients are instructed to report at 0900 AM, and thereafter at 0910, 1100, 1300, 1500, 1700, and 1900 hrs each study day. At these times the patients will receive a sms where they are instructed to immediately rate their pain and stress level and report back.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital of North Norway
• Collaborator: University of Tromso
• Treatments: Ibuprofen

Criteria

Inclusion Criteria:

• Patients must have been diagnosed with radiographic Axial Spondyloarthritis, also called Ankylosing Spondylitis, OR

• Patients must have been diagnosed with non-radiographic 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

• All patients must sign a consent form describing that they will receive placebo during the study period. The Informed Consent Form and The Data Release Form must be signed before inclusion in the studies.

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 rhinitic

• 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