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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: Completed Phase 2 study of Oral Mucositis, sponsored by Izun Pharma.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Degree of oral mucositis will be scored using WHO scoring system bi-weekly throughout course of the trial
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
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2012-03 |
| Est. Completion | 2017-01 |
| Phase | Phase 2 |
What the finished NCT01400620 record still lists
NCT01400620 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, above the 97-participant average among 10 other Oral Mucositis trials with a reported enrollment target (13% higher).
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 lists 10 locations in 3 states (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.
Learn More About Clinical Trials
Similar trials for Oral Mucositis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01400620's enrollment target sits among peer trials
110 3rd of 10 higher than 8 of 10 other Oral Mucositis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Oral Mucositis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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