Conditions: CINV
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 342
Healthy volunteers: no

Brief summary:
Comparison of efficacy of APD403 at preventing delayed sickness in patients who have received cancer chemotherapy

Detailed description:

Arms:
arm 1: OND + DEX + FOS followed by oral DEX arm 2: OND + APD403 followed by oral PLACEBO arm 3: OND + APD403 followed by oral APD403 low dose arm 4: OND + APD403 followed by oral APD403 mid dose arm 5: OND + APD403 followed by oral APD403 high dose

Interventions: intervention 1: Ondansetron intervention 2: Placebo intervention 3: Dexamethasone intervention 4: Fosaprepitant intervention 5: APD403 IV intervention 6: APD403 oral
Intervention descriptions: intervention 1: 5HT3-antagonist intervention 2: Comparator intervention 3: Corticosteroid intervention 4: NK1 antagonist intervention 5: Amisulpride IV 20 mg intervention 6: Amisulpride oral 10, 20 or 40 mg

Protocol document: