Procedural pain treatment with transmucosal sublingual fentanyl tablet in colonoscopy patients

• Conditions: Patients undergoing colonoscopy; MedDRA version: 14.1Level: PTClassification code 10010007Term: ColonoscopySystem Organ Class: 10022891 - Investigations

• Registration Number: EUCTR2011-005688-26-FI
• Lead Sponsor: Turku University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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):