Nausea and/or vomiting MedDRA version: 20.0 Level: LLT Classification code 10014542 Term: Emesis System Organ Class: 100000017043
Conditions
Interventions
Trade Name: Zalasta 10 mg orodispersible tablets
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: OLANZAPINE
CAS Number: 132539-06-1
Concentration unit: mg milligram(s)
Concentration ty
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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Contraindications for olanzapine including allergic reaction, phenylketonuria and diagnosed glaucoma 2. Cardiovascular disease, other than hypertension 3. Parkinson’s disease 4. Dementia 5. Epilepsy 6. Symptoms of increased intracranial pressure or cerebral metastasis. If this is suspected, a normal MR scan of the cerebrum are needed before inclusion 8. Radiologic confirmed ileus, or clinical suspicion evaluated by the study Investigator 9. Cognitive impairment or language barrier that makes the patient unable to complete the questionnaires 10. Surgery to the brain or abdomen within the last 2 weeks or exposure to general anesthesia within the last 4 days. 11. Chemotherapy within the last 2 weeks 12: Radiation therapy targeting the brain or abdomen within the last 2 weeks 12. Pregnancy 13. Reversible causes of nausea/vomiting: e.g. Hypercalcemia, uremia , newly commenced/changed opioid-therapy (within 7 days), other medication with emetic potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objectives: The primary objective is to test if olanzapine 10 mg is effective in patients with advanced cancer not receiving chemotherapy or irradiation. Hypotheses: Administration of olanzapine will result in a change in nausea score from baseline to 24 hours later exceeding 30%. 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 later. ;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 of olanzapine 10 mg for 5 consecutive days. 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): 1. Nauseascore 2. Number of emetic episodes;Timepoint(s) of evaluation of this end point: Recorded at baseline and 24 hours following first dose | — |
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) in the first 24 hours after administration of study medication. 3. Time to first emetic episode. 4. Nausea score 5. Number of emetic episodes. 6. Tolerability of olanzapine 10 mg for 5 consecutive days. 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 and study day 2 + baseline and daily study day 1-7 2. Baseline and study day 2 3. Daily study day 1-7. 4. Baseline and daily study day 1-7 5. Baseling and study day1-7 6: Baseline, study day 2 and 7. 7: Baseline and study day 7 8. Baseline + daily staudy day 1-7. | — |
Countries
Denmark
Contacts
Public ContactSigne Harder
Odense University Hospital
Outcome results
None listed