OncologyPhase 3NCT04217512
Pantoprazole in Cisplatin Nephrotoxicity
A Phase 3 study testing Pantoprazole low dose, Pantoprazole high dose and Standard hydration in people with Oncology, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
Pantoprazole in Cisplatin Nephrotoxicity Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oncology
- What is being tested?
- Pantoprazole low dose, Pantoprazole high dose and Standard hydration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2019to 30 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with head and neck cancer
Who cannot join
- GFR less than 59.
- DM
- Elevated liver enzymes more than 3 fold.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sherief Abd-Elsalam
Tanta
Sherief Abd-Elsalam, Ass. Prof., 00201009221243, sheriefabdelsalam@yahoo.com
About this study
Official title: Possible Protective Effect of Pantoprazole in Cisplatin Induced Nephrotoxicity in Patients With Head and Neck Cancer
Pantoprazole in Cisplatin Nephrotoxicity
Read the detailed description
Pantoprazole in Cisplatin NephrotoxicityPantoprazole in Cisplatin Nephrotoxicity. Is it protective?
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pantoprazole low doseDrug
Also called zurcal
Pantoprazole 0.6 mg/kg
Pantoprazole high doseDrug
Also called zurcal, Controloc
Pantoprazole 1.6 mg\kg
Standard hydrationOther
Also called Hydration
Standard hydration alone
CisplatinDrug
Cisplatin
| Study group | Role | What they receive |
|---|---|---|
| Standard hydration alone | Active comparator | Cisplatin with standard hydration Receives: Other: Standard hydration; Drug: Cisplatin |
| Pantoprazole high dose | Active comparator | Cisplatin with standard hydration with pantoprazole 1.6 mg/kg Receives: Drug: Pantoprazole high dose; Other: Standard hydration; Drug: Cisplatin |
| Pantoprazole Low dose | Active comparator | Cisplatin with standard hydration with pantoprazole 0.6 mg/kg Receives: Drug: Pantoprazole low dose; Other: Standard hydration; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with no renal toxicity
The number of patients with no renal toxicity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start1 May 2019
- Primary completion1 Dec 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Eman M Ghonaim, Msc, Principal investigator, Demonstrator of Clinical PharmacySahar El-Haggar, Prof, Principal investigator, Tanta UniversitySuzy Goher, Lecturer, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217512
- Sponsor's protocol ID
- eman ghoneim
- Status last verified
- Jan 2020
- First submitted
- 29 Dec 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Possible Protective Effect of Pantoprazole in Cisplatin Induced Nephrotoxicity in Patients With Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT04217512
- Acronym / sponsor ID
- eman ghoneim
- Conditions
- Oncology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pantoprazole in Cisplatin Nephrotoxicity
Detailed description
Pantoprazole in Cisplatin NephrotoxicityPantoprazole in Cisplatin Nephrotoxicity. Is it protective?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard hydration alone | Active comparator | Other: Standard hydration, Drug: CisplatinCisplatin with standard hydration |
| Pantoprazole high dose | Active comparator | Drug: Pantoprazole high dose, Other: Standard hydration, Drug: CisplatinCisplatin with standard hydration with pantoprazole 1.6 mg/kg |
| Pantoprazole Low dose | Active comparator | Drug: Pantoprazole low dose, Other: Standard hydration, Drug: CisplatinCisplatin with standard hydration with pantoprazole 0.6 mg/kg |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with head and neck cancer
Key exclusion criteria (3 listed)
- GFR less than 59.
- DM
- Elevated liver enzymes more than 3 fold.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pantoprazole low doseAlso: zurcalPantoprazole 0.6 mg/kg | Drug | Pantoprazole Low dose |
| Pantoprazole high doseAlso: zurcal, ControlocPantoprazole 1.6 mg\kg | Drug | Pantoprazole high dose |
| Standard hydrationAlso: HydrationStandard hydration alone | Other | Pantoprazole Low dose, Pantoprazole high dose, Standard hydration alone |
| CisplatinCisplatin | Drug | Pantoprazole Low dose, Pantoprazole high dose, Standard hydration alone |
Primary outcome
Number of patients with no renal toxicity
Time frame: 6 months
The number of patients with no renal toxicity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eman M Ghonaim, Msc principal investigator
Demonstrator of Clinical Pharmacy
Sahar El-Haggar, Prof principal investigator
Tanta University
Suzy Goher, Lecturer principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pantoprazole low dose, Pantoprazole high dose and Standard hydration in people with Oncology, run by Sherief Abd-Elsalam at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, ass. prof. (00201147773440, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with no renal toxicity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.