Emesis MedDRA version: 18.1 Level: HLT Classification code 10028817 Term: Nausea and vomiting symptoms System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 18.1 Level: LLT Classification code 10014542 Term: Emesis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 18.1 Level: PT Classification code 10028813 Term: Nausea System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: IVEMEND
Product Name: Fosaprepitant
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: fosaprepitant dimeglumine
Other descriptive name: FOSAPREPITANT
Concentration
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Advanced cancer 2. Age = 18 years 3. One or both of the following: 3.1. Nausea at least ‘moderate’ on the baseline diary 3.2. At least 1 emetic episode within the last 24 hours (recorded on the baseline diary) 4. Ability to read and understand the forms required for the study. 5. Life-expectancy more than 2 weeks. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. Contraindications for fosaprepitant including allergic reaction. 2. ALAT > 5 times above normal 3. Symptoms of increased intracranial pressure or cerebral metastasis. If this is suspected, a normal MR scan of the cerebrum are needed before inclusion 4. Radiologic confirmed ileus, or strong clinical suspicion evaluated by the study Investigator 5. Cognitive impairment or language barrier that makes the patient unable to complete the questionnaires 6. Surgery to the brain or abdomen within the last 2 weeks or exposure to general anesthesia within the last 4 days 7. Chemotherapy or radiation therapy within the last 4 weeks 8. Reversible causes of nausea/vomiting: e.g. Hypercalcemia (ion-calcium > 1,5), uremia (eGFR <20 ml/min), hypomagnesemia (p-mg < 0,50), newly commenced/changed opioid-therapy (within 7 days), other medication with emetic potential. 9. Pregnancy 10. Use of strong or moderate inhibitors of CYP3A4 within seven (7) days prior to administration of study drugs (see Section 11.2., “Inhibitors of CYP3A4”). 11. Use of inducers of CYP3A4 within thirty (30) days prior to the administration of study drugs (see Section 11.3., “Inducers of CYP3A4”).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare whether the administration of the neurokinin1-receptor antagonist (NK1-RA) fosaprepitant dimeglumine results in a significant improvement in nausea scores from baseline to 24 hours as compared with placebo. In patients included because of vomiting only (nausea score less than moderate), the primary parameter will be change in number of emetic episodes from baseline to 24 hours.;Secondary Objective: 1. Two-item nausea score and CAT (computer adaptive testing)-score recorded on the ext. EORTC QLQ-C15-PAL at baseline, 24 hours and after 7 days. 2. Number of emetic episodes (vomit/dry retch) in the first 24 hours after administration of study medication. 3. Time to first emetic episode. 4. Nausea score measured daily for 7 days following administration of study medication 5. Number of emetic episodes measured daily for 7 days following the administration of study medication. 6. Tolerability. 7. Parameters indicative of efficacy: appetite, fatigue, pain, emotional function and overall quality of life. 8. Use of rescue anti-emetics. ;Primary end point(s): Change in nausea score If patients included because of vomiting: Change in number of emetic episodes;Timepoint(s) of evaluation of this end point: Baseline and 24 hous following infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Two-item nausea score and CAT (computer adaptive testing)-score 2. Number of emetic episodes (vomit/dry retch). 3. Time to first emetic episode. 4. Nausea score measured daily for 7 days following administration of study medication 5. Number of emetic episodes measured daily for 7 days following the administration of study medication. 6. Tolerability. 7. Parameters indicative of efficacy: appetite, fatigue, pain, emotional function and overall quality of life. 8. Use of rescue anti-emetics. ;Timepoint(s) of evaluation of this end point: 1: Baseline, 24 hours and after 7 days. 2 Baseline and 24 hours 3: Between 0-7 days 4: Daily from study day 0 to study day 7 5: Daily from study day 0 to study day 7 6: Daily from study day 0 to study day 7 7: Baseline and 7 days 8: Daily from study day 0 to study day 7 | — |
Countries
Denmark
Contacts
Public ContactSigne Harder
Odense University Hospital
Outcome results
None listed