Heart Safety Study of Ondansetron in Children Receiving Chemotherapy

NCT01896440 | Withdrawn Phase 4 DMC

• 1 other identifier: Pediatric ondansetron QTc
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

We will study the effects of ondansetron on measurements of electrical activity in the heart to make sure doses we are using to prevent nausea and vomiting in children receiving chemotherapy are safe.

Conditions

Malignant Childhood Neoplasm

Keywords

Pediatric; Ondansetron; Cardiac repolarization; QTc interval

Outcome Measures

Primary Outcomes (1)

• Change in QTc interval

  QTc intervals will be estimated by performing ECGs on patients pre-investigational drug administration and post-investigational drug administration. The change in the QTc interval between the two ECGs for each investigational dose is the primary endpoint.

  Day 1 to 2 months

Study Arms (2)

Group A - standard ondansetron dose first

ACTIVE COMPARATOR

Group A will receive the standard dose of ondansetron (0.15 mg/kg) with the first cycle of chemotherapy and the high dose (0.3 mg/kg) with second cycle.

Drug: Ondansetron

Group B - high dose ondansetron first

ACTIVE COMPARATOR

Group B patients will receive the higher dose of ondansetron (0.3 mg/kg) with the first cycle of chemotherapy and the standard dose (0.15 mg/kg) with the second.

Drug: Ondansetron

Interventions

Ondansetron DRUG

There will be two doses investigated in each arm - standard dose (0.15 mg/kg) and high dose (0.3 mg/kg)

Also known as: Zofran

Group A - standard ondansetron dose first; Group B - high dose ondansetron first

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 6 months to 18 years
• Diagnosis of cancer and receiving 2 identical cycles of chemotherapy within 2 months of each other

You may not qualify if:

• History of cardiac conduction anomalies, myocardial infarction, structural heart abnormalities (even if repaired)
• Pregnant or of child-bearing age and unwilling to take a pregnancy test
• Potassium or calcium outside of reference range at screening
• Liver enzymes (AST/ALT) or bilirubin \>/= 2 x the upper limit of normal at screening

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Ondansetron

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Rene Y McNall-Knapp, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

• Matthew Campbell, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 1, 2013
• First Posted: July 11, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 8, 2013

Record last verified: 2013-10

Locations

US (1)