E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
rotator cuff syndrome and bursitis |
Sindrome de los manguitos rotadores y bursitis |
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E.1.1.1 | Medical condition in easily understood language |
Damage to the rotator cuff (part of the shoulder) and inflammation of the soft tissue around muscles and bones |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006811 |
E.1.2 | Term | Bursitis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039227 |
E.1.2 | Term | Rotator cuff syndrome |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10040611 |
E.1.2 | Term | Shoulder bursitis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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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 of subjective parameters in patients with rotator cuff syndrome and bursitis by visual analogue scale (VAS). |
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E.2.2 | Secondary objectives of the trial |
Evaluation patients with rotator cuff syndrome and bursitis by functional parameters (disability of hand, arm, and shoulder [DASH] score), clinical parameters, and subjective parameters (global assessment by patient and examiner) and safety. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The patients have to meet all of the following inclusion criteria: 1. Male and female patients with acute episodes of chronic rotator cuff syndrome and/or bursitis: tendinopathy of the supraspinatus tendon, bursitis, or partial degenerative tears of the supraspinatus and/or infraspinatus tendon (differentiation by ultrasonography) 2. Age 40 to 65 years, inclusive 3. Willing and able to understand and sign an approved informed consent form 4. Not pregnant (as proven by negative pregnancy test before first study drug administration) or breast-feeding. Females of childbearing potential (including those less than one year post-menopausal) must agree to maintain reliable birth control throughout the study, i.e. an established use of oral, injected or implanted hormonal contraception, female sterilization by hysterectomy, bilateral oophorectomy, or bilateral tubal exeresis, intrauterine device ([IUD] or coil or barrier method (e.g. diaphragm, cervical/vault cap) plus spermicidal cream/gel |
Los pacientes tienen que cumplir todos los criterios de inclusión siguientes: 1. Hombres y mujeres con episodios agudos de síndrome del manguito de los rotadores crónico y/o bursitis: tendinopatía del tendón supraespinoso, bursitis o desgarros parciales degenerativos del tendón supraespinoso y/o infraespinoso (diferenciación mediante ecografía) 2. Edad entre los 40 y los 65 años, ambos inclusive 3. Querer y ser capaz de entender y firmar un documento de consentimiento informado aprobado 4. No estar embarazada (demostrado mediante un resultado negativo en una prueba de embarazo antes de la primera administración del medicamento del estudio) ni en periodo de lactancia. Las mujeres en edad fértil (incluidas aquellas que lleven menos de un año posmenopáusicas) deben acordar utilizar anticonceptivos eficaces durante todo el estudio, es decir, un uso establecido de anticonceptivos hormonales orales, inyectados o implantados, esterilización femenina mediante histerectomía, ooforectomía bilateral o exéresis bilateral de las trompas de Falopio, dispositivo intrauterino (DIU) o anillo vaginal o métodos de barrera (por ej.: diafragma, capuchón cervical) más crema/gel espermicida |
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E.4 | Principal exclusion criteria |
Exclusion Criteria: Potential study patients will be excluded if one of the following exclusion criteria is present: 1. Calcifications in shoulder joint 2. Complete rotator cuff tears 3. Treatment with non-steroidal anti-inflammatory drugs (NSAIDs). Previous treatment with NSAIDs is allowed, with a wash-out period of 1 week; paracetamol can be taken until 48 hours before baseline visit 4. Corticoid therapy by mouth or by injection within the previous 3 months prior to screening 5. Any contraindication for corticoid therapy 6. Physical Therapy, acupuncture, transcutaneous electrical nerve stimulation (TENS) and shock-wave therapy (within 30 days prior to screening) 7. Treatment with anticoagulants (except low-dose aspirin) 8. Diabetic patients including borderline cases (glycosylated fraction of hemoglobin [HbA1c] > 7.0% at screening) 9. Clinically significant shoulder joint deformities 10. Major injury, including sports-related injury, to the shoulder within the past year 11. Significant osteoarthritis of the shoulder 12. Cervical spine disorder (that could confound the clinical assessment) that has been symptomatic and required active treatment within the past three months before screening 13. Any active musculoskeletal disease that could confound the diagnosis/evaluation of the painful shoulder, any neurological aetiology of the pain, or any acute infection of the shoulder joint 14. Any major surgery, arthroplasty, or arthroscopy in the signal shoulder within 6 months of screening or planned surgery within the duration of the study 15. Prior history of any malignancy (with the exception of basal cell carcinoma) treated less than 2 years ago 16. Patients with rheumatic polymyalgia 17. Known or suspected allergies against one or any particular ingredients of Traumeel® S or of other study preparations 18. Presence of serious gastrointestinal, renal, hepatic, pulmonary, cardiovascular, neurological disease or other systemic diseasesknown systemic disease (like leukemia, tuberculosis, immune mediated diseases, multiple sclerosis, Acquired Immuno Deficiency Syndrome, Human Immunodeficiency Virus-infections or other chronic virus-infections) that might interfere with the outcome of the study or the patient?s ability to comply with study requirements 19. Presence of infections and/or skin diseases in the area of the injection site (including psoriasis) 20. Clinically significant abnormal laboratory values (as judged of the investigator) at the screening visit 21. Consumption of any investigational product within one month prior to the screening visit 22. Patients who are likely to be non-compliant or uncooperative during the study, as judged by the investigator. |
Los posibles pacientes del estudio serán excluidos si cumplen alguno de los siguientes criterios de exclusión: 1. Calcificaciones en la articulación del hombro 2. Desgarros completos del manguito de los rotadores 3. Tratamiento con antiinflamatorios no esteroides (AINE). Está permitido el tratamiento previo con AINE, con un periodo de lavado de 1 semana; se puede tomar paracetamol hasta 48 horas antes de la visita basal 4. Tratamiento con corticosteroides orales o inyectables en los 3 meses previos a la selección 5. Alguna contraindicación al tratamiento con corticosteroides 6. Fisioterapia, acupuntura, estimulación nerviosa eléctrica transcutánea (TENS) y terapia con ondas de choque (en los 30 días previos a la selección) 7. Tratamiento con anticoagulantes (excepto aspirina a dosis bajas) 8. Pacientes diabéticos, incluidos los casos limítrofes (fracción glucosilada de hemoglobina [HbA1c] > 7,0% en la selección) 9. Deformidades en la articulación del hombro clínicamente significativas 10. Lesiones mayores, incluidas las lesiones asociadas al deporte, en el hombro en el último año 11. Osteoartritis del hombro significativa 12. Patología de la columna cervical (que podría confundir la evaluación clínica) sintomática y que haya requerido tratamiento activo en los últimos 3 meses antes de la selección 13. Cualquier enfermedad musculoesquelética activa que podría confundir el diagnóstico/la evaluación del hombro con dolor, dolor de cualquier etiología neurológica o cualquier infección aguda de la articulación del hombro 14. Cualquier cirugía mayor, artroplastia o artroscopia en el hombro afectado en los 6 meses anteriores a la selección o cirugía programada durante el estudio 15. Antecedentes de alguna neoplasia maligna (con la excepción del carcinoma basocelular) tratada hace menos de 2 años 16. Pacientes con polimialgia reumática 17. Alergia conocida o sospecha de alergia a alguno de los componentes de Traumeel® S o de los otros preparados del estudio 18. Presencia de enfermedad gastrointestinal, renal, hepática, pulmonar, cardiovascular, neurológica grave u otra enfermedad sistémica conocida (como leucemia, tuberculosis, enfermedades mediadas por el sistema inmunitario, esclerosis múltiple, síndrome de inmunodeficiencia adquirida, infecciones por el virus de la inmunodeficiencia humana u otras infecciones víricas crónicas) que puedan interferir en el resultado del estudio o en la capacidad del paciente para cumplir con los requisitos del estudio 19. Presencia de infecciones y/o enfermedades de la piel en la zona del lugar de inyección (psoriasis incluida) 20. Valores de laboratorio anómalos clínicamente significativos (según el criterio del investigador) en la visita de selección 21. Uso de cualquier producto en investigación en el mes anterior a la visita de selección 22. Pacientes que probablemente no cumplan con el estudio o no cooperen durante el estudio, según el criterio del investigador. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Patient evaluation of shoulder pain (0 - 100 mm VAS scale). The primary efficacy parameter is the patient's assessment of abduction-rotation pain in the target shoulder on a 0 - 100 mm VAS, where 0 corresponds to ?No Pain? and 100 to ?Extreme Pain?. The abduction-rotation will be done with an internal rotation and external rotation and both actively and passively. However, the primary parameter is active rotation abduction with external rotation and only for this movement the VAS will be measured. During the shoulder examination, the active external abduction rotation must be the first movement during evaluation for pain VAS determination. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
D-7, D1, D8, D15, D22, W15 |
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E.5.2 | Secondary end point(s) |
? ROM includes abduction rotation (active external, active internal, passive external, passive internal) measured by goniometry and hand-back range and hand-neck range both measured in cm. ? Jobe with measurement of pain and weakness (positive/negative). ? Painful Arc with measurement of pain (positive/negative). ? Disability of hand, arm, shoulder, score (DASH): Changes from baseline in DASH ? Patient's/Investigator?s Global Assessment. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
ROM, Jobe, Painful Arc, DASH: D-7, D1, D8, D15, D22, W15 Patient's/Investigator?s Global Assessment: D22, W15 |
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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 | 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) | 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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
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
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |