Pain relief during colonoscopy
Conditions
Interventions
Trade Name: PENTHROX
Product Name: PENTHROX
Product Code: MR311
Pharmaceutical Form: Inhalation vapour, liquid
INN or Proposed INN: METHOXYFLURANE
CAS Number: 76-38-0
Current Sponsor code: MR311
Other
Sponsors
Mundipharma Research Limited
Eligibility
Sex/Gender
All
Inclusion 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 F.1.3.1 Number of subjects for this age range 28
Exclusion criteria
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) 11.Uncontrolled diabetes mellitus as evidenced by HbA1c > 8% at screening or known diabetic nephropathy 12.Evidence of clinically significant disease e.g. liver, cardiac, respiratory or malignant disease (e.g., ischemic heart disease, chronic obstructive pulmonary disease, chronic liver disease) based on Investigator assessment of medical notes and/or subject recall, physical examination, laboratory and ECG assessments conducted at screening with ASA 3 or higher 13.Previous possible allergy to the study medication by the subject or relative 14.Any history of hypersensitivity to fluorinated agents 15.Concomitant head injury 16.Unconsciousness 17.Personal or family history of malignant hyperthermia 18.Subjects who have received an investigational medicinal product within 30 days of study entry (defined as the start of the Screening Period). 19.Subjects who are incapable of giving informed consent or complying with the protocol. 20.Subjects who have a history of showing signs of liver or kidney damage after previous methoxyflurane use or halogenated hydrocarbon anaesthesia. 21.Requiring treatment with any prohibited concomitant medications 22.Use of any premedication before the procedure e.g. with sedative or analgesic medications within 24 hours before colonoscopy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate superiority in the efficacy of Penthrox (methoxyflurane) versus placebo based on mean pain profile during colonoscopy, a difference of 1.5 between the two groups can be regarded as clinically meaningful.;Secondary Objective: · Compare efficacy of Penthrox (methoxyflurane) versus placebo based on the key secondary endpoints · Compare the impact on the procedure based on other secondary endpoints · Compare the safety of Penthrox (methoxyflurane) versus placebo based on the safety endpoints;Primary end point(s): Worst pain measured on NRS;Timepoint(s) of evaluation of this end point: Every two minutes until caecum (way in), every 5 min after reaching the caecum (way out), and immediately after colonoscopy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): · Number of responders; a responder is defined as a Subject with an average pain = 3 (mild pain) covering the whole colonoscopy procedure without intake of rescue medication · Pain score at discharge measured on NRS (pain right now) · Anxiety scores before and during procedure measured using STAI-AD and VAS-F. · Need for rescue medication (no of Subjects / amount) · Subject, nurse and colonoscopist satisfaction measured using comfort scale. Other secondary endpoints: · Subject willingness to undergo the same procedure · In-room preparation time measured as time from entering procedure room to start of colonoscopy · Caecal intubation rate measured as (caecum reached? yes/no) · Caecal intubation time measured as time from start of procedure to reaching the caecum · Total colonoscopy time measured as time from start to end of procedure · Rate of polyp and adenoma detection measured as total number detected;Timepoint(s) of evaluation of this end point: As specified within the descriptions of the endpoints above. | — |
Countries
Bulgaria, Finland, Norway, Sweden, United Kingdom
Contacts
Public ContactMedical Operations
Mundipharma Research Limited
Outcome results
None listed