| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| We do not use these products in a concrete disease. We compare the effectiveness of these products to obtain an accurate bowel cleansing before performing a capsule endoscopic study. |
| No usamos estos productos en una patología en concreto, sino que nuestro objetivo es comparar la eficacia de ambos para obtener una adecuada limpieza intestinal en aquellos pacientes que van a ser sometidos a un estudio con cápsula endoscópica |
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| E.1.1.1 | Medical condition in easily understood language |
| We do not use these products in a concrete disease. We compare the effectiveness of these products to obtain an accurate bowel cleansing before performing a capsule endoscopic study. |
| No los usamos en una enfermedad concreta. Nuestro objetivo es comparar su eficacia para obtener una adecuada limpieza intestinal en aquellos pacientes sometidos a un estudio con cápsula endoscópica |
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| E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
| 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 |
| To evaluate the effectiveness of the preparation with PSMC versus the one usually used (PEG) to obtain a correct intestinal cleansing of patients undergoing capsule endoscopy study. The cleanliness level will be measured by a scale designed for this purpose. |
| Evaluar la eficacia de la preparación intestinal con PSMC frente al habitual con PEG en función de la limpieza intestinal de los pacientes sometidos a estudio con CE. El nivel de limpieza se medirá siguiendo una escala diseñada a este fin. |
|
| E.2.2 | Secondary objectives of the trial |
1 - Compare the bowel preparation tolerance between the experimental group (group taking PSMC) and control group (group taking PEG).
2 - Compare adherence to the bowel cleansing protocol between the experimental group (group taking PSMC) and control group (group taking PEG).
3 - Compare the percentage of adverse effects between the experimental group (group taking PSMC) and control group (group taking PEG).
4 - To evaluate the reproducibility of the scale that we have designed to measure intestinal cleansing. |
1- Comparar la tolerancia a la preparación intestinal entre el grupo experimental (grupo que toma el PSMC) y el grupo control (grupo que toma PEG).
2- Comparar la adhesión a la preparación intestinal entre el grupo experimental (grupo que toma el PSMC) y el grupo control (grupo que toma PEG).
3- Comparar el porcentaje de aparición de efectos adversos entre el grupo experimental (grupo que toma el PSMC) y el grupo control (grupo que toma PEG).
4- Evaluar la Reproductibilidad de la escala ideada para medir la limpieza intestinal. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1 - Patients of both sexes, aged above 18 years.
2 - Have any symptom or condition for which is necessary to make a capsule endoscopy study.
3 - Patients who after being informed of the study give written consent for the study. |
1- Pacientes de ambos sexos, mayores de 18 años.
2- Que tengan algún síntoma o patología por el que se le ha indicado un estudio con cápsula endoscópica.
3- Pacientes que tras ser informados del estudio otorguen consentimiento por escrito para la realización del estudio. |
|
| E.4 | Principal exclusion criteria |
1 - Coexistence of severe organic disease that contraindicate making the intestinal cleansingor presenting any medical contraindications to drinking large volumes of fluid (I. Cardiac symptomatic IRenal with CrCl <50%).
2 - contraindication or allergy to any component of the preparations (hypersensitivity to any of the ingredients of the products).
3 - Any medical contraindications included in product sheet: severe dehydration, hypermagnesemia, gastric retention, gastrointestinal ulceration, toxic colitis, toxic megacolon, ileus, nausea and vomiting, ascites, acute surgical abdominal conditions such as appendicitis and obstruction or known or suspected gastrointestinal perforation., rhabdomyolysis as laxatives can induce this condition and may therefore exacerbate. No use in patients with active inflammatory bowel disease known, eg Crohn's disease, ulcerative colitis. Phenylketonuria. Glucose 6-phosphate dehydrogenase deficiency.
3 - In patients with suspected suffering from a bowel obstruction or fistula.
4 - Patients with cognitive impairment that makes it impossible to complete the questionnaires.
5 - Coexisting psychiatric condition that impairs the patient to answer the the questionnaires properly.
6 - Illiteracy and language problems that hinder the realization of the tests.
7 - Pregnancy.
8 - We exclude urgent capsule endoscopy explorations. |
1- Coexistencia de patología orgánica severa que impida o dificulte la toma de la preparación o aquellos que presenten alguna contraindicación médica a la ingesta de grandes volúmenes de líquido (I. Cardíaca sintomática, IRenal con ClCr<50%).
2- Contraindicación médica o alergia a alguno de los componentes de las preparaciones (hipersensibilidad a cualquiera de los ingredientes de los productos).
3- Presentar alguna Contraindicaciónes de la medicación de ficha técnica de los productos: deshidratación grave, hipermagnesemia, retención gástrica, ulceración gastrointestinal, colitis tóxica, megacolon tóxico, íleo, náuseas y vómitos, ascitis, procesos abdominales quirúrgicos agudos tales como apendicitis aguda y obstrucción o perforación gastrointestinal conocida o sospechada., rabdomiolisis ya que los laxantes pueden inducir esta afección y pueden por lo tanto exacerbarla. No usar en pacientes con enfermedad intestinal inflamatoria activa conocida, p.ej., enfermedad de Crohn, colitis ulcerosa. Fenilcetonuria. Déficit glucosa 6 fosfato deshidrogenasa.
3- En pacientes en los que se sospecha, basándose en el cuadro clínico o en las pruebas y registros obtenidos antes del procedimiento, que padecen una obstrucción intestinal o fístulas.
4- Pacientes con deterioro cognitivo que haga imposible cumplimentar los cuestionarios.
5- Coexistencia de patología psiquiátrica que incapacite al paciente la contestación adecuada a los cuestionarios.
6- Analfabetismo o Problemas idiomáticos que dificulten la realización de los tests.
7- Embarazo.
8- Excluiremos las exploraciones solicitadas con carácter urgente, ya que la rapidez con la que se debe realizar la prueba, impide la realización correcta de la dieta que se debe realizar los días previos a la realización de la prueba. |
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| E.5 End points |
| E.5.1 | Primary end point(s) |
Our main hypothesis is that the proposed protocol, based on sodium picosulfate, light magnesium oxide, anhydrous citric acid (PSMC) is more effective than the current protocol, based on polyethylene glycol (PEG), to achieve adequate bowel cleansing in patients undergoing EC to study. Define the degree of bowel cleansing in patients using a scale designed ad hoc for this study.
For this purpouse we will need to include 300 patients. |
| Nuestra hipótesis principal es que el protocolo propuesto, basado en Picosulfato sódico, óxido de magnesio ligero, ácido cítrico anhidro (PSMC) es más eficaz que el protocolo actual, basado en polietilenglicol (PEG), para conseguir una adecuada limpieza intestinal en los pacientes sometidos a estudio con CE. Definiremos el grado de limpieza intestinal de los pacientes mediante una escala diseñada ad hoc en este estudio. Para ello necesitaremos la inclusión en el estudio de 300 pacientes |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
1- PSMC bowel preparation is better tolerated than PEG tolerance being measured by a test designed for this purpose.
2- The degree of patient adherence to the intestinal preparation is greater when using the PSMC that when using PEG.
3- PSMC bowel preparation has a lower percentage of adverse effects than with PEG.
4- The scale we propose to assess bowel cleansing is reproducible for measuring the degree of cleanliness in studies with capsule endoscopy. |
H1 La preparación intestinal con PSMC es mejor tolerado que el PEG siendo la tolerancia medida según un test diseñado para este fin.
H2 El grado de adherencia de los pacientes a la preparación intestinal es mayor cuando se utiliza el PSMC que cuando se utiliza PEG.
H3 La preparación intestinal con PSMC presenta un menor porcentaje de efectos adversos Ej menos dolor abdominal, menos náuseas, menos vómitos, menos dolor de cabeza etc. que con el PEG.
H4 La escala que proponemos para valorar la limpieza intestinal es reproducible para medir el grado de limpieza en los estudios con cápsula endoscópica. |
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | Yes |
| 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) | 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 | Yes |
| 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) | Yes |
| E.8.2.2 | Placebo | No |
| 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
| 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 | 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
|
| The last visit of the last subject will be considered the finsh of the study |
| La última visita del último paciente marca el final de elstudio |
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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 | 7 |
| E.8.9.1 | In the Member State concerned days | |
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