E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
refractory iatrogenic gastrointestinal strictures |
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E.1.1.1 | Medical condition in easily understood language |
difficult-to-treat gastrointestinal strictures |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10078825 |
E.1.2 | Term | Gastrointestinal anastomotic stricture |
E.1.2 | System Organ Class | 100000004863 |
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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 investigate whether intralaesional injection with collagenase clostridium histolyticum (XiapexR) into a stricture followed by dilation 24 hours later improves the outcome of patients with refractory gastrointestinal strictures as compared to dilation alone (standard of care). |
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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 |
The patient is 18-90 years old The patient suffers from a gastrointestinal stricture The stricture is amenable for endoscopic dilation The patient has undergone at least 1 previous endoscopic dilation for the same stricture within the last 3 months The patient has signed the ICF
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E.4 | Principal exclusion criteria |
The patient is not fluent in Dutch |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of repeat dilations that are required over a timespan of 6 months. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
6 months after injection. |
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E.5.2 | Secondary end point(s) |
1) time to first repeat dilation 2) complication rate. 3) For upper gastrointestinal strictures only: Dysphagia/gastric outlet obstruction score (0: able to eat normal diet; 1: moderate passage: able to eat some solid foods; 2: poor passage: able to eat semi-solid foods only; 3: very poor passage: able to drink liquids only; 4: no oral intake possbile) 4) for lower gastrointestinal strictures only: (Ileo)colorectal obstruction scoring system (0, requiring continuous decompression; 1, no oral intake; 2, liquid or enteral nutrition; 3, oral intake of soft solids, low-residue diet, or full diet with symptoms of stricture*; and 4, oral intake of soft solids, low-residue diet, or full diet without symptoms of stricture*. Symptoms of stricture include abdominal pain/cramps, abdominal distension, nausea, vomiting, constipation, and diarrhea which are related to gastrointestinal transit).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
6 months after injection. |
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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 | Yes |
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 | No |
E.8.1.1 | Randomised | No |
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 | 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 | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |