E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
IBD patients undergoing a colonoscopy. |
pazienti con malattia infiammatoria cronica intestinale che si sottopongono a colonscopia. |
|
E.1.1.1 | Medical condition in easily understood language |
IBD patients. |
pazienti con malattia infiammatoria cronica intestinale. |
|
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 | 15.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045282 |
E.1.2 | Term | UC |
E.1.2 | System Organ Class | 100000004856 |
|
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 |
Comparison of 2 preparations for colon cleansing in patients with IBD undergoing a colonoscopy. |
Paragonare la efficacia di due preparazioni intestinali, bisacodile in combinazione con PEG-CS 2 litri e PEG 4 litri, per la pulizia intestinale prima della colonscopia nei pazienti affetti da IBD. |
|
E.2.2 | Secondary objectives of the trial |
Evaluation of safety and tolerability of 2 products. |
Valutare la visibilità mucosa, sicurezza, tollerabilità, gradimento e compliance da parte del paziente dei due prodotti. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adult outpatients (> 18 < 85 yrs), suffering from chronic inflammatory bowel disease, ulcerative colitis and Crohn’s disease, undergoing colonoscopy with different indications. |
Pazienti ambulatoriali di età > 18 anni e < 85, affetti da colite ulcerosa o malattia di Crohn, che devono sottoporsi a colonscopia per varie motivazioni, nel periodo di tempo compreso tra maggio e dicembre 2012. |
|
E.4 | Principal exclusion criteria |
Ileus, intestinal obstruction, toxic megacolon, colon perforation. Severe heart failure (New York Heart Association [NYHA] Class III or IV), acute cardiovascular disease, uncontrolled arterial hypertension (systolic pressure >170 mmHg, diastolic pressure >100 mmHg), severe liver failure or ascites, end-stage renal failure, known or suspected intolerance or allergy to the study products. Women will be excluded from the study if pregnant or breastfeeding. |
Pazienti sottoposti a colonscopia in urgenza, che presentino un quadro di occlusione o sub-occlusione intestinale o di sospetta/accertata perforazione intestinale. Scompenso cardiaco congestizio classe III-IV secondo NYHA, malattie cardiovascolari acute, ipertensione arteriosa incontrollata (sistolica >170 mmHg, diastolica >100mmHg, cirrosi epatica con ascite, insufficienza renale grave. Donne in gravidanza o in allattamento. Intolleranza o allergia a uno dei componenti dei prodotti in preparazione. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Degree of colon cleansig will be assessed by the endoscopist, blind for the cleansing product, using the validated Ottawa scale. |
Valutare il grado di pulizia del colon. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Within 24 hours from the drug administration. |
Entro 24 ore dalla somministrazione del farmaco. |
|
E.5.2 | Secondary end point(s) |
Mucosal visibility according to the presence of bubbles assessed according the Milano scale.
Safety: occurrence of clinically significant adverse events
Tolerability: Occurrence and severity of specific symptoms, related to the product intake, ranked on a scale. They were also asked to rank the severity of specific symptoms, such as bloating, belching, nausea, abdominal pain, vomiting, dizziness, hunger, thirst, anal irritation or headache during the preparation period, as follows: 0 = absent, 1 = mild, 2 = moderate, 3 = severe.
Acceptance of prepration: Patient acceptance of the preparation was evaluated by a predetermined questionnaire assessing interference with daily activity and sleeping, easiness in taking the product and the adjunctive clear fluid and performing the diet. Willingness to repeat the same preparation in the future (Yes/No) was also recorded.
Patient compliance with the study treatment: It was assessed by a nurse who asked the patient whether s/he had completed the dosing regimen as prescribed; compliance was predefined as poor for patients who consumed less than 75% of cleansing solution
Rate of complete colonoscopy and time to reach the coecum. |
Valutare la visibilità mucosa, sicurezza, tollerabilità, gradimento e compliance da parte del paziente dei due prodotti. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Within 24 hours from the drug administration. |
Entro 24 ore dalla somministrazione del farmaco. |
|
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) | 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 | Yes |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
|
|
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 | 40 |
E.8.9.1 | In the Member State concerned days | 0 |