E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the generation, magnitude and duration of the placebo analgesic response in the natural environment of patients with chronic pain. |
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E.2.2 | Secondary objectives of the trial |
Investigate how information about the treatment influence the analgesic effect. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
09:00, 09:10, 11:00, 13:00, 15:00, 17:00 and 19:00 |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Same as the timepoints above |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 7 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial ends after 12 weeks of treatment |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |