E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients undergoing nausea and vomiting following elective colorectal resections |
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MedDRA Classification |
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 |
The DREAMS trial is a 2 stage study: i) a feasibility study and ii) a phase IV randomsied controlled trial. The objective of the feasibility study is to assess the feasibility of running the phase IV study. This pilot trial will develope effective strategies for patient identification, recruitment and follow-up in the main part of the trial. The objective of the full trial is to determine whether dexamethasone reduces postoperative nausea and vomiting in patients undergoing planned major bowel surgery and to determine it's role in future use in this category of patients. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of the phase IV trial is to determine whether there is a measurable benefit during recovery with the use of single dose dexamethasone. Benefits investigated will include quicker return to oral diet and reduced length of stay. The following secondary outcomes will be measured post-operatively. 1. Nausea and vomiting will be measured objectively by recording the frequency of use of post-operative anti-emetics. 2. Nausea will also be measured subjectively by the use of validated visual analogue scale (VAS). 3. Fatigue will be measured using a validated assessment score (FACT – Fatigue questionnaire). 4. Time to tolerate oral diet will be recorded. 5. Length of hospital stay. 6. Health-related quality of life (Euroqol EQ-5D) will be measured using a standardised questionaire. 7. Incremental cost-effectiveness of dexamethasone compared to standard care will also be measured. 8. As we will be using a steroid, we will evaluate patients for increased risks o |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All patients undergoing laparoscopic and open colorectal resections for malignant or benign pathology. |
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E.4 | Principal exclusion criteria |
1. Obstructed procedures 2. Pregnant patients 3. Known adverse reaction to dexamethasone 4. Patients currently taking any form of steroid medication 5. Diabetic/ hyperglycaemic patients 6. Active gastric ulceration 7. Wide-angle glaucoma 8. Patients under the age of 18 9. Patients unable or unwilling to give informed consent |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Episodes of vomiting recorded prospectively on patient care charts. |
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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 | Yes |
E.6.3 | Therapy | Yes |
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) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Standard treatment which is any other anti-emetic |
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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 | 10 |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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 for regulatory purposes is defined as the date of the last visit of the last patient undergoing protocol based treatment. Follow up to 30 days after treatment constitutes the non-interventional phase of 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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |