E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Crampes musculaires chez le patients hémodialysés chroniques.
Muscle cramps happening at dialysis in chronic hemodialysed patients.
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059270 |
E.1.2 | Term | Hemodialysis-induced symptom |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028295 |
E.1.2 | Term | Muscle cramps |
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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 |
Evaluation de l'effet du Cuprum Metallicum 15 CH sur la durée de la première crampe survenue lors de la séance de dialyse.
Evaluation of Cuprum Metallicum 15 CH effect on the duration of the first cramp occuring at dialysis session. |
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E.2.2 | Secondary objectives of the trial |
Effet du Cuprum Metallicum 15 CH sur l'intensité de la crampe. Cuprum Metallicum 15 CH effect in cramp intensity.
Statut de la réponse au traitement. Type of response to treatment after 3 and 6 minutes
Tolérance du traitement à l'essai. Study treatment tolerance. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Critères de sélection / Selection criteria :
- Consentement éclairé écrit obtenu - written informed consent obtained
- âgé de 18 à 85 ans - 18 to 85 years old
- Patient hémodialysé chronique, soumis à 2 à 3 sénaces de dialyse par semaine depuis plus de 6 mois, présentant une pathologie rénale stabilisée. - Chronic hemodyalised patient, i.e. been undergoing 2 to 3 dialysis session a week for more than 6 months, presenting a stabilised renal pathology
- At least one history of cramp at dialysis session in the month preceding the selection visit. - At least one history of cramp at dialysis session in the month precedind the selection visit.
- Patient couvert par un régime de sécurité sociale. - patient under social security protection
Inclusion criteria :
- Patient présentant un épisode de crampe lors de la séance de dialyse. C'est l'apparition de cette crampe en cours de dialyse qui déterminera l'inclusion d'un patient sélectionné. - Patient presenting an episode of cramp at the dialysis session. It is the onset of that cramp during the dialysis session that will determine the inclusion of a selected patient.
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E.4 | Principal exclusion criteria |
Non selection criteria :
- Patient insuffisant rénal présentant une patholgie rénale non stabilisée - Renal failure with non stabilised renal pathology
- Patient dialysé depuis moins de 6 mois - Patient dialysed sinc less than 6 months
- Patient présentant une pathologie associée susceptible de générer des douleurs ou des crampes musculaires pouvant interférer de l'avis de l'investigateur avec les critères de jugement de l'étude - With pains or muscle cramps generating pathology or any pathology considered by the investigator to interfere with evaluation criteria of the study.
- Patient présentant une pathologie psychiatrique sévère, - Patient with a severe psychiatric pathology
- Patiente enceinte ou allaitante - Pregnancy or breast feeding
- Patient en période d'exclusion d'une précedente étude ou participant à un autre essai clinique - patient under exclusion period of o precedent study or participating in another clinical trial
Non inclusion criteria :
- Patient ayant pris un traitement visant à réduire la survenue des crampes musculaires 24 heures avantla visite d'inclusion. - patient having taken a muscle cramp onset reducing treatment 24 hours before the inclusion visit. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Sera considérée comme critère principal, la durée de la crampe musculaire ayant motivée la première prise du traitement alloué. Une comparaison des moyennes de cette durée sera effectuée entre groupe verum et groupe placebo. Les tests statistiques seront réalisés au seuil de 0,05.
Cramp duration following study treatment intake. |
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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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |