NCT04217512

Brief Summary

Pantoprazole in Cisplatin Nephrotoxicity

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
57mo left

Started May 2019

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
May 2019Dec 2030

Study Start

First participant enrolled

May 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 3, 2020

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2030

Last Updated

January 3, 2020

Status Verified

January 1, 2020

Enrollment Period

11.6 years

First QC Date

December 29, 2019

Last Update Submit

January 2, 2020

Conditions

Oncology

Outcome Measures

Primary Outcomes (1)

  • Number of patients with no renal toxicity

    The number of patients with no renal toxicity

    6 months

Study Arms (3)

Standard hydration alone

ACTIVE COMPARATOR

Cisplatin with standard hydration

Other: Standard hydrationDrug: Cisplatin

Pantoprazole high dose

ACTIVE COMPARATOR

Cisplatin with standard hydration with pantoprazole 1.6 mg/kg

Drug: Pantoprazole high doseOther: Standard hydrationDrug: Cisplatin

Pantoprazole Low dose

ACTIVE COMPARATOR

Cisplatin with standard hydration with pantoprazole 0.6 mg/kg

Drug: Pantoprazole low doseOther: Standard hydrationDrug: Cisplatin

Interventions

Pantoprazole low doseDRUG

Pantoprazole 0.6 mg/kg

Also known as: zurcal
Pantoprazole Low dose
Pantoprazole high doseDRUG

Pantoprazole 1.6 mg\\kg

Also known as: zurcal, Controloc
Pantoprazole high dose
Standard hydrationOTHER

Standard hydration alone

Also known as: Hydration
Pantoprazole Low dosePantoprazole high doseStandard hydration alone
CisplatinDRUG

Cisplatin

Pantoprazole Low dosePantoprazole high doseStandard hydration alone

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with head and neck cancer

You may not qualify if:

  • GFR less than 59.
  • Elevated liver enzymes more than 3 fold.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

PantoprazoleCisplatin

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Eman M Ghonaim, Msc

    Demonstrator of Clinical Pharmacy

    PRINCIPAL INVESTIGATOR

  • Sahar El-Haggar, Prof

    Tanta University

    PRINCIPAL INVESTIGATOR

  • Suzy Goher, Lecturer

    Tanta University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherief Abd-Elsalam, ass. prof.

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

December 29, 2019

First Posted

January 3, 2020

Study Start

May 1, 2019

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 30, 2030

Last Updated

January 3, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)