E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
tolerability and efficacy of Lymdiaral Injektopas (Pascoe-Named) |
|
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 |
Evaluate the tolerability of Lymdiaral injektopas (Pascoe-Named) in patients administered with technical IVLC PEFS and ITD |
|
E.2.2 | Secondary objectives of the trial |
Evaluate the efficacy of Lymdiaral injektopas (Pascoe-Named) in patients administered with technical IVLC PEFS and ITD |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Age> 18 years -Suffering from IVLC connected to PEFS |
|
E.4 | Principal exclusion criteria |
Will be excluded from the study subjects who also have one of the following signs or symptoms or conditions: - Secondary Edema to other diseases (disendocrinopatie, kidney disease, liver disease, connective, heart disease). - Patients suffering from incontinence of hemodynamic precludes saphenous-femoral - Pharmacological treatments in progress that may change the evaluation of results (corticosteroids, estrogen-progestine, Ca-antagonists phlebotonic, diuretics). - History pathological autoimmune disorders, neoplastic and paraneoplastic syndromes. - History pathological positive for allergy to medications in general. - Hypersensitivity to one or more components of the product concerned and the composite. -Pharmacological treatments in progress that may change the evaluation of results (corticosteroids, estrogen-progestine, Ca-antagonists, phlebotonic, diuretics) - In Combination with other methods for the same pathology. - Pregnancy - Breastfeeding - In diet therapy treatment - Participation in other clinical studies during the previous six months - Conditions that in the opinion of the physician evaluator, interfere with the ongoing study |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Tolerability of the product Lymdiaral Injektopas(Pascoe-Named) |
|
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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
| |
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 | 12 |
E.8.9.1 | In the Member State concerned days | |
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 | 12 |