E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Oral pain due to oral mucositis in patients undergoing a bone marrow transplant |
Orale smerter på grund af oral mucositis hos patienter der har gennemgået en knoglemarvstransplantation |
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E.1.1.1 | Medical condition in easily understood language |
Oral pain in patients undergoing a bone marrow transplant |
Mundsmerter hos patienter der har gennemgået en knoglemarvstransplantation |
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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 | LLT |
E.1.2 | Classification code | 10028130 |
E.1.2 | Term | Mucositis oral |
E.1.2 | System Organ Class | 100000004856 |
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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 |
After administration of bupivacain lozenges the patients pain due to oral mucositis can be reduced, showed on a Visuel Analog Scale (VAS) 0-10, where as 0 = No pain and 10 = worst pain ever |
Nedsætte patienternes oral mucositis smerter, vist ved lavere scoring på den Visuelle Analog Skala (VAS) 0-10, hvor 0 = ingen smerter og 10 = værst tænkelige smerter, efter administration af bupivacain sugetablet. |
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E.2.2 | Secondary objectives of the trial |
- Reduce the use of opioids administered by a Patient Controlles Analgesia (PCA) pump - Improve the patients nutrition messuerede by weight and food intake - Improve the patients quality og life messuerede by a questionnaire |
- Nedsætte forbruget af opioider administreret vha. PCA pumpe - Forbedre patienternes ernæring målt ud fra vægt- og kostregistrering, - Forbedre patienternes livskvalitet målt ud spørgeskema.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Scheduled for a bone marrow transplant - Age between 18 and 80 years old - Ability to speak, read and understand danish - Ability to give written and oral consent |
- Skal gennemgå en knoglemarvstransplantation - Alder mellem 18 og 80 år - I stand til at tale, læse og forstå dansk - Skal kunne afgive informeret skriftligt samtykke
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E.4 | Principal exclusion criteria |
- Known allergy towards bupivacaine or other local analgesia of the amide type - Pregnancy - Breastfeeding women |
- Kendt allergi overfor bupivacain eller andre lokalanalgetika fra amidgruppen - Graviditet - Ammende kvinder
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E.5 End points |
E.5.1 | Primary end point(s) |
VAS evaluation of oral pain when administration of the lozenge |
VAS scoring af orale smerter i forbindelse med administration af sugetablet
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Timepoint for administration of the lozenge - Number of lozenges administrated per day - Opioid use administrated from a "Patient controlled anesthesia" (PCA) pump - Number of failed attempt to get opioids from the PCA pump - Weightloss - Food intake |
- Tidspunkt for administration af sugetablet - Antal sugetabletter administreret pr. dag - Morfinforbrug fra PCA pumpe - Antal tryk på PCA der ikke udløser morfin - Vægt - Kostindtag |
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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 | 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 | 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 | 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 | 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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LVLS |
Sidste patient sidste forsøgsdag |
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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 | 0 |