E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
outpatients with past poor bowel preparation, defined as a score less than 5, according to the Boston scale |
pacientes ambulatorios con antecedente de mala preparación colorrectal, definido según la Clasificación de Boston como una puntuación inferior a 5 |
|
E.1.1.1 | Medical condition in easily understood language |
patients scheduled for a colonoscopy, who had poor cleansing in the last colonoscopy |
sujetos a los que se les ha indicado la realización de una colonoscopia y ésta no es valorable por mala calidad de la limpieza colónica, |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] |
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 compare a 4l PEG based intensive colonic cleansing with another one based on 2l PEG plus ascorbic acid in patients with past poor colon preparation. |
Comparar la eficacia en la limpieza colónica de dos estrategias de limpieza colónica intensiva una utilizando alto volumen (4 litros de polietilenglicol) y otra de bajo volumen (2 litros de polietietilenglicol y ácido ascórbico) en pacientes a los que se les indica la realización de una colonoscopia y que se han preparado previamente de forma inadecuada. |
|
E.2.2 | Secondary objectives of the trial |
1) To compare the degree of tolerance between the two preparations. 2) To compare the detection rate of colorectal neoplasia |
comparar el grado de tolerancia entre ambas preparaciones. y la tasa de detección de neoplasia colorrectal. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
? Age> 18 years ? Outpatients with a history of past poor bowel prep, defined according to the Boston scale as a score less than 5. (26) ? Signed informed consent |
? Edad >18 años ? pacientes ambulatorios con antecedente de mala preparación colorrectal, definido según la Clasificación de Boston como una puntuación inferior a 5.26 ? Firma del consentimiento informado |
|
E.4 | Principal exclusion criteria |
paralytic ileus, intestinal obstruction, megacolon, poorly controlled hypertension (systolic pressure> 180, dyastolic pressure> 100), congestive heart failure, acute liver failure, end stage renal disease (dialysis or pre-dialysis), New York Heart Association class III-IV, pregnancy, diagnosis of phenylketonuria, diagnosis of glucose-6-phosphate dehydrogenase deficiency, dementia, prior inclusion. The informed consent will be required for all subjects who met the inclusion criteria and none of the exclusion. |
ileo, obstrucción intestinal, megacolon, hipertensión arterial mal controlada (HTAS >180 HTAD >100), insuficiencia cardiaca congestiva, fallo hepático agudo, insuficiencia renal terminal (diálisis o pre-diálisis), NYHA III-IV, embarazo, lactancia, diagnóstico de fenilcetonuria, diagnóstico de deficit de glucosa-6-fosfato deshidrogenasa, demencia con dificultad para la ingesta de la preparación, inclusión previa. A todos los sujetos que cumplan los criterios de inclusión y ninguno de los de exclusión se les solicitará el consentimiento informado. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
colonic cleansing assessed by a validated cleansing scale (Boston scale). |
limpieza colónica evaluada mediante una escala de limpieza validada (escala de Boston). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
In colonoscopy examination, two days from starting treatment. |
En el momento de la colonoscopia, a los dos días de inicio de la limpieza colónica. |
|
E.5.2 | Secondary end point(s) |
to assess the tolerance by a visual analog scale and the detection of colorectal lesions. |
evaluar la tolerancia mediante escalas visuales analógicas y la detección de lesiones colorrectales evaluada mediante la pieza histológica. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
In colonoscopy examination, two days from starting treatment. |
En el momento de la colonoscopia, a los dos días de inicio de la limpieza colónica. |
|
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) | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | 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
| 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
|
last visit of the last subject undergoing the trial |
última visita del último paciente reclutado |
|
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 | 2 |
E.8.9.1 | In the Member State concerned days | 0 |