EUCTR2017-003767-35-SE
Active, not recruiting
Phase 1
A randomised, double-blind, parallel group study comparing patient controlled analgesia with Penthrox® (methoxyflurane) versus placebo during colonoscopy - MEthoxyflurane in Acute coloNoScopy pain: MEANS randomised controlled trial
ConditionsPain relief during colonoscopyTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
DrugsPENTHROX
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Pain relief during colonoscopy
- Sponsor
- Mundipharma Research Limited
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Referred for colonoscopy for clinical indications or cancer screening
- •2\.Males and females, age \= 18 years.
- •3\.Female Subjects less than one year post\-menopausal must have a negative urine pregnancy test prior to the first dose of study medication, and be non\-lactating.
- •4\.Written informed consent obtained from the Subject indicating that they understand the purpose of, and procedures required, for the study and are willing to participate in it.
- •5\.Ability to understand the use of the Penthrox (Methoxyflurane) inhaler.
- •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 52
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •1\.Pregnancy or lactation period (women only)
- •2\.Previous colorectal resections
- •3\.Same\-day bi\-directional endoscopy
- •4\.Subjects having a pain score (pain right now) \> 2 as assessed by a NRS score (0 – 10\) at baseline
- •5\.Subjects with any condition e.g. extreme anxiety judged by the Investigator to interfere with correct administration of Penthrox (Methoxyflurane) inhaler
- •6\.Diagnosed anxiety disorders
- •7\.Concomitant treatment with psychotropic drugs including benzodiazepines
- •8\.Active alcohol or drug abuse and/or history of opioid abuse
- •9\.Renal impairment defined as creatinine \>1\.5 x ULN measured at screening
- •10\.Subjects taking any potential nephrotoxic drugs (e.g. aminoglycosides)
Outcomes
Primary Outcomes
Not specified
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