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NCT01400620 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Oral Mucositis, sponsored by Izun Pharma.

Completed
Registry status
Phase 2
Development phase
110
Enrollment target
10
Study locations

NCT01400620 is a Phase 2 study of Oral Mucositis that has completed, run by Izun Pharma. The registered enrollment target is 110 participants, above the 97-participant average among 10 other Oral Mucositis trials with a reported enrollment target (13% higher). The trial reports 10 study locations across 3 states.

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The verdict

NCT01400620, a Phase 2 study of Oral Mucositis, has completed, sponsored by Izun Pharma.

COMPLETED
Registry status
Phase 2
Development phase
110 participants
Enrollment target
10
Study locations

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

2 total trials

What the Registry Record Tells You About NCT01400620

The ClinicalTrials.gov registry entry for NCT01400620 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 97-participant average among 10 other Oral Mucositis trials with a reported enrollment target (13% higher). The listed sponsor is Izun Pharma, which has 2 total studies on file at ClinicalTrials.gov.

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.

NCT01400620 reports 10 study locations spanning 3 distinct geographic areas - top geographies include Other, Florida, New York.

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.

What interventions are being tested in trial NCT01400620?

The interventions under investigation include: IZN-6N4 (DRUG).

Who is sponsoring clinical trial NCT01400620?

This trial is sponsored by Izun Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.