E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Early gastrointestinal lesions in the upper gastrointestinal tract.
Our study is not looking at the direct treatment of any particular condition, but the early detecton of lesions. When performing upper gastrointestinal endoscopy it is a common problem to find views obscured by mucous and foam. We therefore intend to use n-acetyl cysteine and Simeticone as a mucolytic agent, potentially improving views of the mucosa and therefore enabling early detection of small lesions. |
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E.1.1.1 | Medical condition in easily understood language |
A cleansing drink given prior to upper gastrointestinal endoscopy (flexible camera examination of the gullet and stomach) may improve views and lead to better detection of abnormal areas. |
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E.1.1.2 | Therapeutic area | Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] |
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 | 10014809 |
E.1.2 | Term | Endoscopy gastrointestinal |
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 |
To determine if a pre-endoscopy drink of simeticone/n-acetylcysteine (a solution which will disperse bubbles and dissolve mucus) will improve views during upper gastrointestinal endoscopy (a flexible endoscopy camera examination of the gullet, stomach and duodenum). The solution will be compared to a simple water pre-endoscopy drink or no preparation. |
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E.2.2 | Secondary objectives of the trial |
To see if use of the solution of simeticone/n-acetylcysteine reduces the number of cleansing fluid flushes that need to be given during the procedure, and also reduces the duration of the procedure. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients undergoing upper gastrointestinal endoscopy at Portsmouth Hospitals NHS Trust |
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E.4 | Principal exclusion criteria |
• Cases where there is significant oesophagitis preventing accurate assessment • Emergency cases (eg gastrointestinal bleeding) • Patients who would already receive NAC/Simethicone pre-endoscopy as part of their standard care • Patients with a known stricture or stenosis (narrowing) • Pregnant or breastfeeding women • Patients with a known upper gastrointestinal malignancy • Patients with a previous CVA resulting in pharyngeal weakness or paralysis • Patients with bulbar or pseudobulbar palsy • Patients with a history of previous oesophageal or gastric surgery • Patients who are currently in another clinical trial • Patients with a known allergy to NAC or Simeticone • Patients without the capacity to give informed consent
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean visibility mucosal score.
Digital photographs will be taken at 4 pre-defined locations (Lower oesophagus/Upper body greater curve/Antrum/Fundus) during the procedure prior to any mucosal flushing. These images will be scored for mucosal visibility.
Photographs will be rated for mucosal visibility by four experienced endoscopists (scorers). Visibility scores are rated on a four point scale (1 = no adherent mucus and clear views of the mucosa, 2 = a thin coating of mucus but not obscuring views of the mucosa, 3 = mucus/bubbles partially obscuring views of the mucosa, 4 = heavy mucus/bubbles obscuring views of the mucosa. Therefore total score based on 4 photographs ranges from 4 (best) to 16 (worst) for each scorer.
The scorers will be trained in the use of the visibility score with photographic examples prior to scoring the study photographs. A pre-study test will be performed to check that there is sufficient inter-observer agreement before the study photographs are scored (Kappa value >0.4). The scorers will be blinded to the pre-endoscopy preparation relating to each photograph and the average of the four total scores will be used for each patient.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Photgraphs will be taken during the procedure. These will rated later once all study photographs have been collected. |
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E.5.2 | Secondary end point(s) |
1) Total procedure duration 2) Volume of fluid flushes required to achieve adequate mucosal views |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Duration and volume of flushes used will be documented on the CRF at the end of the procedure. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
1)Drink of plain water 2)No drink |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
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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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 | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |