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BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron

NCT04150614 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-11-12

No results posted yet for this study

Summary

Patients undergoing either an autologous or allogeneic hematopoietic stem cell transplant (HSCT) and receiving preparative chemotherapy experience a considerable amount of chemotherapy-induced nausea and vomiting (CINV). Current strategies at reducing CINV in this patient population are suboptimal due to lack of efficacy and supportive evidence, potential for increased adverse events, and drug-drug and drug-disease contraindications.

Conditions

  • Nausea With Vomiting Chemotherapy-Induced

Interventions

DRUG

Granisetron Transdermal Patch

Antiemetic

DRUG

Intravenous Dexamethasone

Antiemetic

DRUG

Ondansetron

ondansetron

Sponsors & Collaborators

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Karen Sweiss, PharmD · University of Illinois at Chicago

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-14
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04150614 on ClinicalTrials.gov