Procedural pain treatment with transmucosal sublingual fentanyl tablet in colonoscopy patients

INTERVENTION: Trade Name: Abstral Product Name: Abstral Pharmaceutical Form: Sublingual tablet INN or Proposed INN: FENTANYL CITRATE CAS Number: 990‐73‐8 Pharmaceutical form of the placebo: Sublingual tablet Route of administration of the placebo: Sublingual use CONDITION: Patients undergoing colonoscopy ; MedDRA version: 14.1 Level: PT Classification code 10010007 Term: Colonoscopy System Organ Class: 10022891 ‐ Investigations PRIMARY OUTCOME: Main Objective: The purpose of this study is to evaluate the efficacy of fentanyl transmucosal tablet to placebo in patients having colonoscopy. Primary end point(s): Secondary Objective: INCLUSION CRITERIA: The patients are recruited from 18‐85 year old male or female patients undergoing colonoscopy Criteria for inclusion: 1. ASA I‐III 2. Colonoscopy 3. Written informed consent from participating subject Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range