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NCT02635984 · ClinicalTrials.gov registry record · Phase 3
Study of FOND Versus FOND+O for the Prevention of CINV in Hematology Patients Receiving Highly Emetogenic Chemotherapy Regimens
A Phase 3 study of Hematologic Neoplasms and Complications of Bone Marrow Transplant, sponsored by Augusta University.
- Completed
- Registry status
- Phase 3
- Development phase
- 108
- Enrollment target
- 1
- Study location
NCT02635984: Completed Phase 3 study of Hematologic Neoplasms and Complications of Bone Marrow Transplant, sponsored by Augusta University.
NCT02635984 is a Phase 3 study of Hematologic Neoplasms and Complications of Bone Marrow Transplant that has completed, run by Augusta University. The registered enrollment target is 108 participants, below the 1,021-participant average among 20 other Hematologic Neoplasms trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02635984, a Phase 3 study of Hematologic Neoplasms and Complications of Bone Marrow Transplant, has completed, sponsored by Augusta University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 108 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Overall percentage of patients who had a complete response (CR) defined as no emesis and minimal nausea (\< 25 mm on a 100 mm visual analog scale \[VAS\]) during the overall assessment period (starting day 1 of chemotherapy and continuing for 5 days after discontinuation of chemotherapy) for the first cycle of chemotherapy.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Olanzapine
Study Locations (1)
Georgia
- Augusta University Medical Center - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2015-11 |
| Est. Completion | 2017-12 |
| Phase | Phase 3 |
What the finished NCT02635984 record still lists
NCT02635984 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 1,021-participant average among 20 other Hematologic Neoplasms trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Hematologic Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02635984 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT02635984 about?
NCT02635984 is a clinical study titled "Study of FOND Versus FOND+O for the Prevention of CINV in Hematology Patients Receiving Highly Emetogenic Chemotherapy Regimens". 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...
What is the current status of trial NCT02635984?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 108 participants. The study started on 2015-11. Estimated completion is 2017-12.
What conditions does trial NCT02635984 study?
This clinical trial studies the following conditions: Hematologic Neoplasms, Complications of Bone Marrow Transplant.
What interventions are being tested in trial NCT02635984?
The interventions under investigation include: Placebo (DRUG), Olanzapine (DRUG).
Who is sponsoring clinical trial NCT02635984?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02635984 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02635984's enrollment target sits among peer trials
108 10th of 20 higher than 11 of 20 other Hematologic Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hematologic Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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