E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Calcific tendinitis of shoulder |
Tendinitis calcificante de hombro |
|
E.1.1.1 | Medical condition in easily understood language |
Shoulder tendinitis |
Tendinitis de hombro |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
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 |
Solanum malacoxylon 9CH efficacy |
Determinar la eficacia de Solanum malacoxylon 9CH |
|
E.2.2 | Secondary objectives of the trial |
Determine clinical improvement, measured in terms of improvement in pain, function and mobility. Assess patient satisfaction Compare the use of NSAIDs Determine the safety profile |
Determinar la mejoría clínica, medida en términos de mejoría del dolor, funcionalidad y movilidad. Valorar la satisfacción de los pacientes Comparar la utilización de AINEs Determinar el perfil de seguridad |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
? Patients who have given written informed consent. ? Patients of both sex with age ? 18 years in the screening visit. ? Diagnosis of calcifying tendinitis of shoulder confirmed by image (standard radiography [Rx] and / or ultrasound in the 3 months prior to study treatment. |
?Pacientes que hayan otorgado su consentimiento informado por escrito. ?Pacientes de ambos sexos con edad igual o superior a 18 años en la visita de selección. ?Diagnóstico de tendinitis calcificante de hombro confirmado mediante imagen (radiografía estándar [Rx] y/o ecografía en los 3 meses previos al inicio del tratamiento de estudio. |
|
E.4 | Principal exclusion criteria |
? Women pregnant or nursing. ? Patients receiving homeopathic treatment. ? Patients candidates for scheduled within 2 months following surgery. ? Patients who have been treated with corticosteroids (oral or infiltrate) or invasive procedure (shock waves, ultrasound, etc.) in the past 3 months. ? Patients who are unwilling or unable to comply with the protocol. |
?Mujeres embarazadas o en lactancia. ?Pacientes que estén recibiendo un tratamiento homeopático. ?Pacientes que sean candidatos a cirugía programada en los 2 meses siguientes. ?Pacientes que hayan recibido tratamiento con corticoides (oral o infiltrado) o procedimiento invasivo (ondas de choque, ultrasonidos, etc.) en los últimos 3 meses. ?Pacientes que no quieran o no puedan cumplir con el protocolo. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in lesion area measured by ultrasonography |
Cambio en el área de lesión, medida mediante ecografía |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
End of treatment |
Al final del tratamiento |
|
E.5.2 | Secondary end point(s) |
Cinical improvement Satisfaction with treatment Consumption of NSAIDs |
Mejoría clínica Satisfacción con el tratamiento Consumo de AINEs |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
End of treatment |
Al final del tratamiento |
|
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 | No |
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) | 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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |