E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Irritable bowel syndrome |
Síndrome de intestino irritable |
|
E.1.1.1 | Medical condition in easily understood language |
Irritable bowel syndrome |
Sindrome de intestino irritable |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10023003 |
E.1.2 | Term | Irritable bowel syndrome |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
|
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 |
Evaluate possible predictors of response to linaclotide, specifically the prevalence of pain on the altered bowel (proportion pain / constipation), which can allow the identification of profiles of IBS patients who would benefit from treatment |
Evaluar posibles factores predictores de respuesta a linaclotida, específicamente el predominio de dolor sobre la alteración del tránsito intestinal (proporción dolor/estreñimiento), que puedan permitir la identificación de los perfiles de pacientes con SII que más se beneficiarían del tratamiento |
|
E.2.2 | Secondary objectives of the trial |
asses whether the response at 4 weeks predicts response at 12 weeks Evaluate the impact of linaclotide on non-intestinal symptoms, digestive and non-digestive, associated with IBS. |
Evaluar si la respuesta a las 4 semanas predice la respuesta a las 12 semanas. Evaluar el impacto de linaclotida sobre los síntomas no intestinales, digestivos y no digestivos, asociados al SII. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Age betwen 18 and 70 years old 2. Sex: male and female 3. Meet the Rome III criteria for the diagnosis of constipation predominant IBS 4. Moderate-severe constipation IBS, defined as a score greater than 175 points IBSSS 5. Clinical explorations to support the diagnosis of IBS: a. All patients: blood in less than six months that shows no anemia b. Over 50 years: colonoscopy to the cecum without abnormalities explaining the symptoms in the last five years. 6. Sign informed consent: Patients should give informed consent in writing and must be able to read and understand it. |
1. Edad: mayor de 18 e inferior a 70 años 2. Sexo: ambos sexos 3. Cumplir criterios de Roma III para el diagnóstico de SII con predominio estreñimiento 4. SII estreñimiento moderado-grave, definido como una puntuación del IBSSS mayor a 175 puntos 5. Exploraciones complementarias para soportar el diagnóstico de SII: a. Todos los pacientes: análisis de sangre en menos de 6 meses que no muestre anemia b. Mayores de 50 años: colonoscopia hasta ciego sin hallazgos que justifiquen los síntomas en los últimos 5 años. 6. Firma del consentimiento informado escrito: Los pacientes deberán otorgar un consentimiento informado escrito y deberán ser capaces de leer y comprender el mismo. |
|
E.4 | Principal exclusion criteria |
1. Women of childbearing age who are unwilling or unable to use valids methods of contraception during the study period and up to 4 weeks after finishing. 2. Women of childbearing age who use an invalid method of contraception. 3. Pregnant or breast-feeding. 4l. Women with a positive pregnancy test at the time of enrollment or prior to study drug administration. |
1. Las mujeres en edad fértil que no quieran o no puedan usar un método anticonceptivo aceptable durante todo el periodo del estudio y hasta 4 semanas después de finalizado el estudio. 2. Mujeres en edad fértil que utilicen un método anticonceptivo prohibido. 3. Mujeres embarazadas o en periodo de lactancia. 4. Mujeres con un resultado positivo en el test de embarazo en el momento de la inclusión o antes de la administración del fármaco del estudio. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Clinical response at 12 weeks defined as a subjective improvement on a Likert scale of "Cataloging opinion of the answer" as better or much better compared to baseline and accompanied by a decrease IBSSS score above 30% of baseline or achieve a score below 75 points |
respuesta clínica a las 12 semanas definida como una mejoría subjetiva en una escala Likert de ?Catalogación subjetiva de la respuesta? como mejor o mucho mejor respecto a la situación basal y acompañado de una disminución de la puntuación del IBSSS superior al 30% de la basal o alcance una puntuación por debajo de 75 puntos |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
baseline, week 4 and week 12 |
al inicio, semana 4 y semana 12 |
|
E.5.2 | Secondary end point(s) |
Anxiety-depresion Score, PHQ12 Score Non intestinal digestive symptoms Score fear / worry Score Confidence in the drug baseline severity (IBSSS) |
Score de ansiedad-depresión, Score PHQ12 (síntomas extradigestivos), Score de sintomas digestivos no intestinales, Score miedo/preocupación, Score de confianza en el fármaco, Gravedad basal (IBSSS) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
baseline, week 4 and weeek 12 |
inicio, 4ª semana y 12ª semana |
|
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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 | 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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 8 |
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
|
LVLS |
ultima visita del ultimo paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |