E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Colonoscopy is the most common investigation of the colon. Bowel cancer screening has been shown to reduce deaths from bowel cancer. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10010007 |
E.1.2 | Term | Colonoscopy |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Does continuous use of Entonox® reduce pain severity during colonoscopy? |
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E.2.2 | Secondary objectives of the trial |
Does continuous use of Entonox® during colonoscopy increase side effects compared to as required? Does continuous use of Entonox® during colonoscopy increase patient satisfaction? Does continuous use of Entonox® during colonoscopy increase willingness to have a repeat colonoscopy? Does continuous use of Entonox® during colonoscopy reduce the need for additional analgesia? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria are those patients attending for a screening colonoscopy through the Bowel Cancer Screening Programme who wish to start their colonoscopy with Entonox® alone. |
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E.4 | Principal exclusion criteria |
The exclusion criteria are the usual contraindications to the use of Entonox® which include; severe respiratory disease, bullous emphysema, pneumothorax, middle ear disease, sinusitis and recent head injury and previous intolerance.
Other exclusion criteria are a history of previous colectomy / colonic resection, and refusal to enter the trial.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure will be the recollection of pain during colonoscopy when asked prior to leaving the endoscopy department. Prior to leaving patients will be asked the standard question of ‘between 0 and 10, on average, how much pain have you had during the colonoscopy?’ |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The time point for this is prior to the patient leaving the endoscopy department. |
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E.5.2 | Secondary end point(s) |
Secondary end points will be: 1) Recollection of overall pain levels 2) Experience of pain during colonoscopy. 3) Willingness to have a repeat colonoscopy. 4) Overall satisfaction 5) need for additional analgesia or sedation 6) Side effects |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) Recollection of overall pain levels will be asked immediately following colonoscopy and 1-3 days following colonoscopy. 2) Patients experience of pain will be asked every 2 minutes during colonoscopy. The mean pain level, peak pain level and total (area under curve) will be calculated for each patient and treatment strategy. 3) Willingness to have a repeat colonoscopy will be asked prior to discharge and 1-3 days following the colonoscopy. 4)Overall patient satisfaction will be asked prior to discharge and 1-3 days following colonoscopy 5) Need for additional analgesia or sedation will be measured during colonoscopy. 6) The incidence of side effects will be monitored during and immediately after colonoscopy |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
continuous versus 'as required' administation |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial will be when the last subject has been contacted by the BCSP nurse 1-3 days following their colonoscopy. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 14 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 17 |