E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with anal fistula |
Los pacientes tienen diagnosticada una fistula anal compleja del tipo criptoglandular con un orificio interno y uno externo. |
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E.1.1.1 | Medical condition in easily understood language |
Although most fistulas are simple and can be solved easily fewer cases of them are complex, since it must preserve continence, while eradicates the suppurative process |
Aunque la mayoría de las fístulas son simples un menor número de ellas son complejas, constituyendo un reto puesto que debe preservarse la continencia, a la vez que erradica el proceso supurativo |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
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 |
The aim of the study was to evaluate the efficacy and safety of plasma rich in growth factors as adjuvant to curettage and simple closure of the internal orifice compared to a control group (serum) in patients with complex cryptoglandular anal fistulas. Efficacy and safety will be monitored for a total of 12 months after completion of treatment.
Primary objective To assess efficacy by the proportion of responders after 12 months of treatment, compared with responders to placebo. |
El objetivo del estudio es evaluar la eficacia y seguridad del plasma rico en factores de crecimiento como adyuvante al curetaje y cierre simple del orifico interno en comparación con un grupo control (suero) en pacientes con fistulas anales criptoglandulares complejas. Se realizará un seguimiento de la eficacia y seguridad durante un total de 12 meses después de la finalización del tratamiento.
Objetivo primario Evaluar la eficacia mediante la proporción de pacientes respondedores al cabo de los 12 meses de terminado el tratamiento, comparando con los respondedores al placebo. |
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E.2.2 | Secondary objectives of the trial |
Secondary Objectives
The secondary efficacy endpoints (comparing both groups) are as follows: - Evaluate the clinical response - total or partial - at each visit and at the end of the trial, with respect to the baseline data. - Evaluate the time to clinical remission - total or partial - defined at each visit and at the end of the trial, compared to the baseline data. - Evaluate the response by endoanal ultrasound / MRI at the end of the trial with respect to baseline ultrasound data. - Evaluate the variations in the quality of life assessed by the Quality of Life Questionnaire SF36 at each visit and at the end of the trial, compared to the baseline data.
The safety assessment will be part of the secondary endpoints and will include potential PRFG adverse events measured by recording adverse events reported during the study and the clinical findings of physical examination. The evaluation will also consider the assessment of fecal incontinence. |
Objetivos secundarios - Evaluar la respuesta clínica –total o parcial-, en cada visita y a la finalización del ensayo, respecto a los datos basales. - Evaluar el tiempo hasta la remisión clínica –total o parcial- definida en cada visita y a la finalización del ensayo, respecto a los datos basales. - Evaluar la respuesta mediante ecografía endoanal/RM al final del ensayo respecto a los datos ecográficos basales. - Evaluar las variaciones de la calidad de vida, valorada mediante el Cuestionario de calidad de vida SF36 en cada visita y a la finalización del ensayo, respecto a los datos basales.
La evaluación de la seguridad formará parte de los criterios de valoración secundarios e incluirá los posibles acontecimientos adversos de PRFG, medida mediante el registro de los acontecimientos adversos notificados durante el estudio y los hallazgos clínicos de la exploración física. En dicha evaluación se considerará también la valoración de incontinencia fecal. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Signature of consent, age greater than 18 years and complex fistulas of cryptoglandular origin with a single path, and equal number of internal and external holes. |
Firma de consentimiento, edad mayor de 18 años y fístulas anales de origen criptoglandular complejas con un único trayecto, e igual número de orificios interno y externos. |
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E.4 | Principal exclusion criteria |
Non-resolved interposed or coexisting collections, non-localization of the internal orifice, simple fistula (submucosal / subcutaneous / low-interphosphorylated), pregnant, active or past cancer in less than 5 years, HIH, anal stricture to prevent anal fistula exploration, allergy To the sealing product used, rectovaginal fistulas, active or non-rectal inflammatory disease, inability to follow up, platelet antiplatelet therapy that can not be discontinued at least one week before surgery and one week later patients receiving Currently any investigational drug, or have received it within 3 months prior to enrollment in this clinical trial. |
Colecciones interpuestas o coexistentes no resueltas, no localización del orificio interno, fístula simples (submucosas/subcutáneas/interesfinterianas bajas), embarazadas, cáncer activo o pasado en menos de 5 años, HIH, estenosis anal que impida la exploración de la fístula anal, alergia al producto de sellado empleado, fístulas rectovaginales, enfermedad de inflamatoria activa o no de recto, imposibilidad de cumplimiento del seguimiento, toma de antiagregante plaquetario que no pueda ser suspendido al menos una semana antes de la cirugía y una semana después, pacientes que estén recibiendo actualmente cualquier fármaco en investigación, o lo hayan recibido en los 3 meses previos a la inscripción en este estudio clínico. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The fistula is considered cured when the external fistula orifice, are closed and / or does not drain after compression finger. Persistence of symptoms after three months of surgery: recurrence and / or failure of treatment is considered. |
La Fístula se considera curada cuando el orificio fistuloso externo, esta cerrado y/o no drena, tras compresión con dedo. Se considera recurrencia y/o fracaso de tratamiento: persistencia de síntomas después de tres meses de la cirugía. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At three, six, and twelve months after treatment |
A los 3, 6 y 12 meses post tratamiento |
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E.5.2 | Secondary end point(s) |
The safety assessment will be part of the secondary endpoints and include possible adverse events PRGF measured by recording adverse events reported during the study and clinical findings of the physical examination. The evaluation will also consider the evaluation of fecal incontinence. |
La evaluación de la seguridad formará parte de los criterios de valoración secundarios e incluirá los posibles acontecimientos adversos de PRFG, medida mediante el registro de los acontecimientos adversos notificados durante el estudio y los hallazgos clínicos de la exploración física. En dicha evaluación se considerará también la valoración de incontinencia fecal |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At three, six, and twelve months after treatment |
A los 3, 6 y 12 meses post tratamiento |
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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) | 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
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complete cure, defined as 1 year after discharge or no stained by OFE and this is completely re-epithelized. A partial cure when within 1 year after the seal has not stained by oozing or OFE, but it is completely reepithelized NO. The primary efficacy was measured at each follow-up period (1, 3, 6 months), the secondary efficacy measure after one year follow-up after treatment |
curación completa, se define cuando al cabo de 1 año no presenta supuración ni manchado por el OFE y este se encuentra totalmente reepitelizado. Un curación parcial cuando al cabo de 1 año posterior al sellado no presenta supuración ni manchado por el OFE, pero el éste NO se encuentra totalmente reepitelizado. La eficacia primaria se medirá en cada periodo de seguimiento (1, 3, 6 meses), la eficacia secundaria se medirá al cabo de un año de seguimiento tras tratamiento |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |