Patients undergoing colonoscopy MedDRA version: 14.1 Level: PT Classification code 10010007 Term: Colonoscopy System Organ Class: 10022891 - Investigations
Conditions
Interventions
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
Sponsors
Turku University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. A previous history of intolerance to the study drug or related compounds and additives 2. History of alcoholism, drug abuse, psychiatric, psychological or other emotional problems that are likely to invalidate informed consent 3. Sleep apnoea 4. Chronic obstructive pulmonary disease 5. BMI = 35 or weight < 50 kg 6. SpO2 < 90 % 7. Concomitant drug therapy known to cause significant enzyme induction or inhibition of CYP 3A4. 8. Pregnancy or nursing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to evaluate the efficacy of fentanyl transmucosal tablet to placebo in patients having colonoscopy.;Secondary Objective: ;Primary end point(s): | — |
Countries
Finland
Outcome results
None listed