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A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TWO DIFFERENT DOSES OF PALONOSETRON COMPARED TO ONDANSETRON IN THE PREVENTION OF CINV IN PEDIATRIC PATIENTS UNDERGOING SINGLE AND REPEATED CYCLES OF MEC OR HEC

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TWO DIFFERENT DOSES OF PALONOSETRON COMPARED TO ONDANSETRON IN THE PREVENTION OF CINV IN PEDIATRIC PATIENTS UNDERGOING SINGLE AND REPEATED CYCLES OF MEC OR HEC

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-068-11
Enrollment
35
Registered
2011-09-26
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

THE LOWER PALONOSETRON DOSE IS 10 mcg/kg UP TO A MAXIMUM OF 0.75 mg, THE HIGHER PALONOSETRON DOSE IS 20 mcg/kg UP TO A MAXIMUM DOSE OF 1.50 mg, WHILE THE ONDANSETRON DOSE IS 0.15 mg/kg GIVEN EVERY 4 H

Sponsors

Helsinn HealthCare S.A,
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 17 Years

Inclusion criteria

Inclusion criteria: 1. WRITTEN INFORMED CONSENT SIGNED BY PARENT(S)/LEGAL GUARDIANS OF THE TO PEDIATRIC PATIENT IN COMPLIANCE WITH THE LOCAL LAWS AND REGULATIONS. IN ADDITION SIGNED CHILDREN´S ASSENT FORM ACCORDING TO LOCAL REQUIREMENTS. 2. MALE OR FEMALE IN- OR OUT-PATIENTS FROM NEONATES (FULL TERM) TO 2.5 ULN OR ALT > 2.5 ULN OR TOTAL BILIRUBIN > 1.5 ULN): IN THE INVESTIGATOR´S OPINION THE IMPARMENT SHOULD NOT JEOPARDIZE PATIENT´S SAFETY DURING THE STUDY.

Exclusion criteria

Exclusion criteria: 1. THE PATIENT AND/OR PARENTS/CAREGIVERS ARE EXPECTED BY THE INVESTIGATOR TO BE NON-COMPLIANT WITH THE STUDY PROCEDURES. 2. LACTATING OR PREGNANT FEMALE PATIENT. 3. PATIENT HAS RECEIVED TOTAL BODY IRRADIATION, RADIOTHERAPY OF THE UPPER ABDOMEN, LOWER THORAX REGION, OR CRANIUM/CRANIOSPINAL REGIONS OR THE PELVIS WITHIN 1 WEEK PRIOR TO STUDY ENTRY (SCREENING). 4. SCHEDULED TO RECEIVE COCOMITANT TOTAL BODY IRRADIATION, RADIOTHERAPY OF THE UPPER ABDOMEN, LOWER THORAX REGION, OR CRANIUM/CRANIOSPINAL REGIONS UP TO 24 HOURS AFTER STUDY DRUG ADMINISTRATION. 5. KNOWN HISTORY OF ALLERGY TO ANY COMPONENT OR OTHER CONTRAINDICATIONS TO ANY 5-HT3 RECEPTOR ANTAGONIST. 6. ACTIVE INFECTION. 7. UNCONTROLLED MEDICAL CONDITION (eg, UNCONTROLLED INSULIN-DEPENDENT DIABETES MELLITUS). 8. MARKED BASELINE PROLONGATION OF QTc INTERVAL [QTcB or QTcF > 460 MSEC] IN ANY OF THE ECG ASSESSMENTS AT SCREENING. FOR THIS PURPOSE, ASSESSMENT WILL RELY ON THE AUTOMATIC INTERPRETATION BY THE ECG MACHINE.

Countries

Argentina, Austria, Bulgaria, Chile, Czech Republic, Estonia, France, Germany, Hungary, Peru, Poland, Romania, Russian Federation, Ukraine, United States

Contacts

Public ContactBruno Eduardo Olcese

PSI CRO Peru S.A.C.

bolcese@olceseabogados.com372-0527 / 372-1009

Outcome results

None listed

Source: REPEC (via WHO ICTRP)