NCT04181346

Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting

Phase II Study of Pregabalin for the Prevention of Chemotherapy Induced Nausea and Vomiting

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Faculdade de Medicina do ABC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

phase II randomized, double-blind, placebo-controlled trial to investigate whether pregabalin can improve the complete control of nausea and vomiting (primary end point)

Detailed description

chemotherapy-naive patients, scheduled to receive moderately and highly emetogenic chemotherapy. All patients will receive IV ondansetron 8 mg, dexamethasone 10 mg and ranitidine 50 mg before chemotherapy on day 1 and oral dexamethasone 4 mg, bd, on days 2 and 3. Patients will be randomly assigned to take pregabalin 75 mg or placebo, bd, from the night before chemotherapy to day 5.

Conditions

• Nausea

Interventions

Type	Name	Description
DRUG	Pregabalin	antipsychotic
DRUG	Placebo	Placebo

Timeline

• Start date: 2019-09-01
• Primary completion: 2020-02-28
• Completion: 2020-02-28
• First posted: 2019-11-29
• Last updated: 2019-11-29

Locations

1 site across 1 country: Brazil