Pantoprazole in Cisplatin Nephrotoxicity

NCT ID: NCT04217512

Last Updated: 2020-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2030-12-30

Brief Summary

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Pantoprazole in Cisplatin Nephrotoxicity

Detailed Description

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Pantoprazole in Cisplatin NephrotoxicityPantoprazole in Cisplatin Nephrotoxicity. Is it protective?

Conditions

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Oncology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard hydration alone

Cisplatin with standard hydration

Group Type ACTIVE_COMPARATOR

Standard hydration

Intervention Type OTHER

Standard hydration alone

Cisplatin

Intervention Type DRUG

Cisplatin

Pantoprazole high dose

Cisplatin with standard hydration with pantoprazole 1.6 mg/kg

Group Type ACTIVE_COMPARATOR

Pantoprazole high dose

Intervention Type DRUG

Pantoprazole 1.6 mg\\kg

Standard hydration

Intervention Type OTHER

Standard hydration alone

Cisplatin

Intervention Type DRUG

Cisplatin

Pantoprazole Low dose

Cisplatin with standard hydration with pantoprazole 0.6 mg/kg

Group Type ACTIVE_COMPARATOR

Pantoprazole low dose

Intervention Type DRUG

Pantoprazole 0.6 mg/kg

Standard hydration

Intervention Type OTHER

Standard hydration alone

Cisplatin

Intervention Type DRUG

Cisplatin

Interventions

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Pantoprazole low dose

Pantoprazole 0.6 mg/kg

Intervention Type DRUG

Pantoprazole high dose

Pantoprazole 1.6 mg\\kg

Intervention Type DRUG

Standard hydration

Standard hydration alone

Intervention Type OTHER

Cisplatin

Cisplatin

Intervention Type DRUG

Other Intervention Names

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zurcal zurcal, Controloc Hydration

Eligibility Criteria

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Inclusion Criteria

* Patients with head and neck cancer

Exclusion Criteria

* GFR less than 59.
* DM
* Elevated liver enzymes more than 3 fold.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sherief Abd-Elsalam

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

Ass. Prof. Tropical Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Eman M Ghonaim, Msc

Role: PRINCIPAL_INVESTIGATOR

Demonstrator of Clinical Pharmacy

Sahar El-Haggar, Prof

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Suzy Goher, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Locations

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Sherief Abd-Elsalam

Tanta, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sherief Abd-Elsalam, ass. prof.

Role: CONTACT

00201147773440

Facility Contacts

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Sherief Abd-Elsalam, Ass. Prof.

Role: primary

00201009221243

Other Identifiers

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eman ghoneim

Identifier Type: -

Identifier Source: org_study_id

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