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COMPLETED Phase 2

Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer

NCT01400620 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to determine whether an oral rinse composed of botanical extracts is effective in the prevention of severe inflammation of the lining of the oral cavity caused by chemotherapy and radiation therapy for head and neck cancer.

Conditions Studied

Interventions

  • DRUG IZN-6N4

Study Locations (10)

Other

  • Soroka Medical Center — Beersheba
  • Rambam Medical Center — Haifa
  • Rabin Medical Center - Beilinson Campus — Petah Tikva
  • Sourasky Medical Center — Tel Aviv
  • Assuta Medical Center — Tel Aviv
  • Sheba Medical Center — Tel Litwinsky

Florida

  • UF Health Cancer Center — Gainesville
  • University of Miami-Sylvester CCC Clinical Research Services — Miami

New York

  • Mount Sinai Beth Israel - Phillips Ambulatory Care Center — New York
  • NYU Clinical Cancer Center — New York

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2012-03
Est. Completion 2017-01
Phase Phase 2

Sponsor

Izun Pharma

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01400620

The ClinicalTrials.gov registry entry for NCT01400620 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Izun Pharma, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Oral Mucositis appearing as the primary indexed condition, and to 1 intervention — of which IZN-6N4 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01400620 reports 10 study locations spanning 3 distinct geographic areas — top geographies include Other, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01400620 about?

NCT01400620 is a clinical study titled "Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer". The purpose of this study is to determine whether an oral rinse composed of botanical extracts is effective in the prevention of severe inflammation of the lining of the oral cavity caused by chemotherapy and radiation therapy for head and neck cancer.

What is the current status of trial NCT01400620?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2012-03. Estimated completion is 2017-01.

What conditions does trial NCT01400620 study?

This clinical trial studies the following conditions: Oral Mucositis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01400620?

The interventions under investigation include: IZN-6N4 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01400620?

This trial is sponsored by Izun Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01400620 being conducted?

This trial has 10 study locations across Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial