EUCTR2013-000098-65-NO
Active, not recruiting
Not Applicable
Treatment of Axial Spondyloarthritis with reduced doses of NSAIDs: Application of pharmacotherapeutic conditioning in clinical practice.
niversity of Tromsø0 sitesJune 21, 2013
ConditionsAxial SpondyloarthritisTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
DrugsIbumetin 400 mg
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Axial Spondyloarthritis
- Sponsor
- niversity of Tromsø
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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