E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Complex regional pain syndrome type 1. This condition is a pain syndrome with unknown pathophysiology. Research shows that inflammation plays a role in the development and course of the disease. Evidence is low on best treatment, but scavengers such as DMSO, and corticosteroids are described to be benificial. |
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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 |
Reduction of inflammatory signs and symptoms of CRPS patients after treatment with DMSO or corticosteroids. |
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E.2.2 | Secondary objectives of the trial |
Assessment of safety of treatment with high dosage corticosteroids. Follow up of inflammatory markers in urine and blood plasma after corticosteroid and DMSO treatment. Course of sensory, autonomic and motor disturbances as measured by the McGill Pain Questionnaire, Pain Box scores, Range of motion, volumetric and temperature assessments significantly in both groups. Assessment of the functional status of the affected extremity as measured by the Walking Ability Questionnaire for lower extremity CRPS-1, and Radboud Skills Questionnaire for upper extremity CRPS-1. Health related quality of life as measured by the SF-36.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Complex regional pain syndrome type 1 (diagnosed using the Budapest criteria)
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E.4 | Principal exclusion criteria |
Not being able to give informed consent, another (2nd) chronic pain syndrome, interfering with pain ratings, another syndrome interfering with functional tests, CRPS-1 in both hands or feet, known kidney insufficiency or severe liver disease, active infection, mental retardation, psychiatric abnormality, malignant disease, pregnancy, established severe osteoporosis, established gastric ulcera, hypersensitivity or allergy to prednisolone, use of anti-coagulantia, myasthenia gravis, previous use of DMSO for a period longer than 1 month.
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E.5 End points |
E.5.1 | Primary end point(s) |
ISS score, a validated compound score consisting of difference in temperature, volume, pain and motor functions between the extremity with CRPS and the contralateral extremity. |
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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 | Yes |
E.6.5 | Efficacy | Yes |
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 | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
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 | Information not present in EudraCT |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |