CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 108 enrolled
Drug / intervention
Olanzapine +1 moredrug
Likely dose
Olanzapine 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02635984
NCT02635984Phase 3Completed
CompareCT.gov

Randomized, Placebo Controlled Study of FOND (Fosaprepitant, Ondansetron, Dexamethasone) Versus FOND+O (FOND Plus Olanzapine) for the Prevention of Chemotherapy Induced Nausea and Vomiting in Hematology Patients Receiving Highly Emetogenic Chemotherapy Regimens

Augusta University·interventional·Posted Dec 21, 2015·Updated Aug 20, 2018

In Brief

A Phase 3 clinical trial evaluating Olanzapine and Placebo for Complications of Bone Marrow Transplant and Hematologic Neoplasms. Completed, enrolled 108 participants across 1 site.

Detailed Summary

The objective of this study is to compare the effectiveness of olanzapine added to standard triplet therapy (fosaprepitant, ondansetron, and dexamethasone) versus triplet therapy alone in preventing chemotherapy-induced nausea and vomiting (CINV) in hematology patients receiving highly or moderately emetogenic chemotherapy regimens.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsComplications of Bone Marrow Transplant, Hematologic Neoplasms
CountriesUnited States
CollaboratorsUniversity of Georgia

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 21, 2015
Enrollment StartNov 1, 2015
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.5 years ago

Interventions

Olanzapinedrug

Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy

Placebodrug

Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy