E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Adult patients with fractures of the distal radius. |
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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 |
Does vitamin C improve hand and wrist function following fractures of the distal radius? |
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E.2.2 | Secondary objectives of the trial |
- Does vitamin C reduce the incidence of reflex sympathetic dystrophy following fractures of the distal radius? - Does vitamin C increase the rate of fracture healing after fractures of the distal radius? - What is the influence of polymorphic variations in the glutathione perioxidase 1 gene on the clinical outcome after wrist fractues and the on the response to vitamin C treatment? |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
· Adult patients (>18 years of age) · Unilateral extra-articular or minimal articular un-displaced and displaced distal radial fractures treated with cast, external fixation or open reduction and internal fixation · Patients willing and able to consent · Patients available for review (@ 2, 6, 12 and 26 weeks and 1 year)
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E.4 | Principal exclusion criteria |
· Patients on vitamin C therapy prior to fractures · Previous distal radial fracture on affected side · Bilateral distal radial fractures · Articular displacement requiring open reduction and internal fixation · Patients who are demented or unable to consent · Patients with history of renal calculi (possible hyperoxaluria) · Patients with a history of glucose 6-phosphate dehydrogenase deficiency and hyperoxaluria · Patients with chronic renal failure
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end points or outcome measure si hand and wrist function as assessed by measurement of pain, grip strength, active range of movements and the ability to perform the activities of daily living: - Pain is assessed by a 10 cm visual analogue score and recording of analgesic use - Grip strength is measured by using a JAMAR hand dynamometer - Active range of movements is measured by using a standard full circle goniometer with recordings in triplicate to reduce intra-observer bias. - Ability of perform daily activities is assessed using the standardised "Disabilities of the arm, shoulder and hand (DASH) outcome questionnaires". |
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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 | Information not present in EudraCT |
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) | 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 | 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) | 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 | Information not present in EudraCT |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |