E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Topical local anesthesia for upper gastrointestinal endoscopy |
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E.1.1.1 | Medical condition in easily understood language |
Topical local anesthesia for upper gastrointestinal endoscopy |
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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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10024760 |
E.1.2 | Term | Local anesthetic |
E.1.2 | System Organ Class | 100000004865 |
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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 |
To determine if placebo is non-inferior to viscous lidocaine for upper gastrointestinal endoscopy |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients referred to and found fit for upper GI endoscopy in an out patient setting Between 18 and 75 years old Speaks and understands Danish |
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E.4 | Principal exclusion criteria |
Patients admitted for upper GI endoscopy in an in-patient setting Patients with dementia and/or other cognitive dysfunction disorders Patients primarly complaining of dysphagia Patients allergic to lidocaine Patients with suspected retention Patients who will undergo upper GI endoscopy with nurse-assisted propofol sedation Patients who will undergo upper GI endoscopy with assistance of anesthesia-personnel |
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E.5 End points |
E.5.1 | Primary end point(s) |
Ease of intubation [Time Frame: Immediately after the procedure] The endocopist will rate the difficulty of intubating the esophagus on a numeric rating scale NRS 0-10 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Immediately after the procedure |
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E.5.2 | Secondary end point(s) |
Ease of examination [Time Frame: Immediately after the procedure] The endocopist will rate the difficulty of performing the endoscopy on a numeric rating scale NRS 0-10
Number of intubation attempts [Time Frame: Peroperatively counted by the assisting nurse] Total number of intubation attempts until the esophagus is reached
Number of gag reflexes [Time Frame: Peroperatively counted by the assisting nurse] Total number of gag reflexes during the examination
Patient's perception of discomfort [Time Frame: Immediately after the procedure] The patient's self-evaluation of discomfort during the examination on a numeric rating scale, 0-10
Patient's willingness to be reexamined [Time Frame: Immediately after the procedure] The patient's willingness to have the procedure performed again in the future on a numeric rating scale, 0-10
Sedation 1 [Time Frame: Peroperatively] Number of milligrams midazolam administered during the procedure
Sedation 2 [Time Frame: Peroperatively] Number of milligrams alfentanil administered during the procedure
Perception of gag reflexes [Time Frame: Immediately after the procedure] The endoscopist's rating of the patient's degree of gag reflexes, numeric rating scale 0-10
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
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 | Yes |
E.8.2.3 | Other | No |
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.8.5 | 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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Last visit of the last subject |
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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 | |