E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pain due to intramuscular injection in syphilis. |
Dolor secundario a inyección intramuscular en sífilis. |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10062120 |
E.1.2 | Term | Syphilis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 |
Analyze if administration of penicillin in patients with syphilis with 19G needle, with or without lidocaine is associated with a reduction in pain compared to intramuscular administration with a 21G needle with or without lidocaine in the intramuscular injection. |
Analizar si la administración de Penicilina en pacientes con sífilis mediante aguja 19G, asociado o no a lidocaína se relaciona con una reducción del dolor en la inyección intramuscular comparado con la administración con una aguja de 21G con o sin Lidocaína en la inyección intramuscular. |
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E.2.2 | Secondary objectives of the trial |
To analyze the evolution of pain after administration of intramuscular penicillin in patients with syphilis at 6 and 24 h after injection with a 19 G needle with or without lidocaine versus injection administered with a 21 G needle with or without lidocaine. |
Analizar la evolución del dolor tras la administración de Penicilina intramuscular en pacientes con sífilis a las 6h y 24 h posteriores a la inyección con una aguja 19 G con o sin lidocaína frente a la inyección administrada con una aguja 21 G con o sin Lidocaína. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Support diagnosis of syphilis by serology (syphilis IgG + / + VDRL / TPHA + RPR + with) in the presence or absence of symptoms or clinical signs. Need for treatment with intramuscular penicillin 2400000 U. Acceptance to participate in the study after signing the informed consent. |
Diagnóstico de sífilis mediante serología compatible (Sífilis IgG+/VDRL+/TPHA+ junto con RPR+), en presencia o no de síntomas o signos clínicos compatibles. Necesidad de tratamiento con Penicilina intramuscular 2400000 U. Aceptación a participar en el estudio tras la firma del consentimiento informado. |
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E.4 | Principal exclusion criteria |
Diagnosis of neurosyphilis associated with possible impairment of sensory perception of pain after administration of the drug. Cognitive impairment who are unable or have difficulty understanding and evaluating the degree of pain on the visual analogue scale (VAS). Background hipersensibililidad to beta-lactams. Known hypersensitivity to lidocaine. Confinement in prison. |
Diagnóstico de neurosífilis relacionado con posible alteración de la percepción sensorial del dolor tras la administración del fármaco. Deterioro cognitivo que sean incapaces o tengan dificultades para comprender y evaluar el grado del dolor en la escala analógica visual (EVA). Antecedentes de hipersensibililidad a betalactámicos. Antecedentes de hipersensibilidad a Lidocaína. Reclusión en centros penitenciarios. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Pain evolution after administration of intramuscular penicillin. |
Evolución del dolor tras la administración de Penicilina intramuscular. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline, 6 and 24 hours post-injection. |
Basal, 6 y 24 horas post-inyeción. |
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E.5.2 | Secondary end point(s) |
Demographic: Age, sex, etnic orign. Anthropometric: Weight, height, BMI, circumference arm and thigh. Pathological: HIV Infection; RPR value at the time of the inclusion in the study and 6 months later; clinical stage of syphilis (primary, secondary, latent). Ischemic lesions, neurological deficits due to ischemic compromise of the sciatic nerve; paresis and paralysis corresponding to the injection member. Discoloration and loss of function of the member to administration area. Local irritant reaction. |
Demográficas: Edad, sexo, raza. Antropométricas: Peso, talla, índice de masa corporal, circunferencia del brazo y del muslo. Patológicas: Infección VIH; Valor del RPR en el momento de la inclusión en el estudio y 6 meses después; estadio clínico de la sífilis (primaria, secundaria, latente). Lesiones isquémicas, déficits neurológicos por compromiso isquémico del nervio ciático; paresias y parálisis del miembro correspondiente a la zona de inyección. Cambio de coloración e impotencia funcional del leg correspondiente a la zona de administración. Reacción irritativa local. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline, 6 and 24 hours post-injection. |
Basal, 6 y 24 horas post-inyeción. |
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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 | 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.8.2.4 | Number of treatment arms in the trial | 4 |
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
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LVLS |
Última visita del último paciente. |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |