- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04217512
Pantoprazole in Cisplatin Nephrotoxicity
January 2, 2020 updated by: Sherief Abd-Elsalam
Possible Protective Effect of Pantoprazole in Cisplatin Induced Nephrotoxicity in Patients With Head and Neck Cancer
Pantoprazole in Cisplatin Nephrotoxicity
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Pantoprazole in Cisplatin NephrotoxicityPantoprazole in Cisplatin Nephrotoxicity.
Is it protective?
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tanta, Egypt
- Recruiting
- Sherief Abd-Elsalam
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with head and neck cancer
Exclusion Criteria:
- GFR less than 59.
- DM
- Elevated liver enzymes more than 3 fold.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Standard hydration alone
Cisplatin with standard hydration
|
Cisplatin
Standard hydration alone
Other Names:
|
ACTIVE_COMPARATOR: Pantoprazole high dose
Cisplatin with standard hydration with pantoprazole 1.6 mg/kg
|
Cisplatin
Standard hydration alone
Other Names:
Pantoprazole 1.6 mg\kg
Other Names:
|
ACTIVE_COMPARATOR: Pantoprazole Low dose
Cisplatin with standard hydration with pantoprazole 0.6 mg/kg
|
Cisplatin
Standard hydration alone
Other Names:
Pantoprazole 0.6 mg/kg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with no renal toxicity
Time Frame: 6 months
|
The number of patients with no renal toxicity
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eman M Ghonaim, Msc, Demonstrator of Clinical Pharmacy
- Principal Investigator: Sahar El-Haggar, Prof, faculty of pharmacy- Tanta University
- Principal Investigator: Suzy Goher, Lecturer, faculty of pharmacy- Tanta University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2019
Primary Completion (ANTICIPATED)
December 1, 2030
Study Completion (ANTICIPATED)
December 30, 2030
Study Registration Dates
First Submitted
December 29, 2019
First Submitted That Met QC Criteria
January 2, 2020
First Posted (ACTUAL)
January 3, 2020
Study Record Updates
Last Update Posted (ACTUAL)
January 3, 2020
Last Update Submitted That Met QC Criteria
January 2, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- eman ghoneim
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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