E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ivestigations hypotheses: 1. NSAIDs provide a significant postoperative pain relief that can make mobilization / rehabilitation faster and easier oedema prophylaxis. 2. NSAIDs do not affect bone healing or affect so little that it will not lead to consequences (delayed or absent healing, osteoporosis, instability) of clinical significance. 3. Radiological assessment of secondary dislocation of fractures, DEXA - scanning and bone marker tests are equally sensitive to detect bone effects.
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009924 |
E.1.2 | Term | Colles' fracture |
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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 |
Primary point: assessment of radiological secondary dislocation: any migration larger than in the other group will be an expression of instability and thus slower or absent healing. It is possible to determine the migration of approx. 0.5 mm and 1 ° accuracy. Incidence of secondary dislocations and those, which need an operation, will be manufactured in absolute and percentage figures. |
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E.2.2 | Secondary objectives of the trial |
Secondary points: movements of the wrist joint, DASH (function) score; pain measured by VAS-score (patients complete pain diary in the first 2 weeks postoperatively); noted consumption of painkillers, which is prescribed ‘as needed’; Bone mineral density measured by DEXA scanner: it will be examined whether there are significant differences between density measurement of healthy radius at the beginning of treatment and 3 months later, is there a significant difference between broken and healthy bone mineralization; bone markers: Serum Cross Laps ELISA ®, N-Mid ® Osteocalcin ELISA; bone biopsy from callus zone: assessed ossification and maturity of the callus , which are presented in histomorphometric numbers: bone and fibrous tissue volume fraction, osteoid thickness. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Written acceptance to participate in the study, reposition and / or surgery demanding Colles fracture, which needs to be fixed with external fixation. |
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E.4 | Principal exclusion criteria |
Age - younger than 50 years or older than 80 years; treatment with prednisolon; NSAIDs - treatment; previous fracture or surgery at the wrist; lack of mental and physical capacity to follow studies’ instructions; lack of informed consent; other diseases can affect bone substance (oncology, endocrine diseases), medical contraindications to NSAIDs use, smoking, alcohol consumption more than 14 drinks per week, secondary dislocation of fracture also apply as exclusion criterion. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary point: assessment of radiological secondary dislocation: any migration larger than in the other group will be an expression of instability and thus slower or absent healing. It is possible to determine the migration of approx. 0.5 mm and 1 ° accuracy. Incidence of secondary dislocations and those, which need an operation, will be manufactured in absolute and percentage figures. Secondary points: movements of the wrist joint, DASH (function) score; pain measured by VAS-score (patients complete pain diary in the first 2 weeks postoperatively); noted consumption of painkillers, which is prescribed ‘as needed’; Bone mineral density measured by DEXA scanner: it will be examined whether there are significant differences between density measurement of healthy radius at the beginning of treatment and 3 months later, is there a significant difference between broken and healthy bone mineralization; bone markers: Serum Cross Laps ELISA ®, N-Mid ® Osteocalcin ELISA; bone biopsy from callus zone: assessed ossification and maturity of the callus , which are presented in histomorphometric numbers: bone and fibrous tissue volume fraction, osteoid thickness.
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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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
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 | Yes |
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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End of the trial when the last patient makes his/her last visit unles primar data shows clear tendency for delayed fracture heal - in this case the trial will be stopped befor the term. |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 7 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |