NCT01400620 is a Phase 2 clinical trial of IZN-6N4 in Oral Mucositis, sponsored by Izun Pharma Ltd.

Who is sponsoring NCT01400620?

NCT01400620 is sponsored by Izun Pharma Ltd.

What drugs are being tested in NCT01400620?

Interventions in NCT01400620: IZN-6N4.

What condition does NCT01400620 study?

NCT01400620 studies Oral Mucositis.

Is NCT01400620 still recruiting?

NCT01400620 is currently completed. Last updated 12 March 2018.

Last reviewed 2018-03-12 · How we verify

NCT01400620

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase 2 Study to Evaluate the Safety and Efficacy of IZN-6N4 for the Prevention of Chemo-Radiation-Induced Oral Mucositis in Patients With Head and Neck Cancer

Completed Phase 2 Last updated 12 March 2018

What this trial tests

Phase 2 trial testing IZN-6N4 in Oral Mucositis in 110 participants. Completed in 1 January 2017.

Timeline

1 March 2012

Primary endpoint
1 January 2017

1 January 2017

Quick facts

Lead sponsor	Izun Pharma Ltd
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	110
Start date	1 March 2012
Primary completion	1 January 2017
Estimated completion	1 January 2017
Sites	10 locations across United States, Israel

Drugs / interventions tested

IZN-6N4 — full drug profile →

Conditions studied

Oral Mucositis — all drugs for Oral Mucositis →

Sponsor

Izun Pharma Ltd — full company profile →

Who can join

18 and older, any sex, with Oral Mucositis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Proportion of WHO score 3-4 Oral Mucositis at a Cumulative Radiation Dosage of 50 Gy in the active and Placebo Groups
Time frame: Participants will be assessed twice per week during the duration of chemoradiation therapy anticipated to be 5-7 weeks. Following chemoradiation therapy the participants will be assessed weekly for two weeks.
Degree of oral mucositis will be scored using WHO scoring system bi-weekly throughout course of the trial

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Radiation-Induced Oral Mucositis.
Maria OM, Eliopoulos N, Muanza T. · · 2017 · cited 253× · PMID 28589080 · DOI 10.3389/fonc.2017.00089
Oral Mucositis: An Update on Innate Immunity and New Interventional Targets.
Chen C, Zhang Q, Yu W, Chang B, et al · · 2020 · cited 44× · PMID 32479139 · DOI 10.1177/0022034520925421
Ionizing radiation: molecular mechanisms, biological effects, and therapeutic targets.
Wei W, Ren Y, Lan J, Yi J, et al · · 2026 · PMID 41507636 · DOI 10.1186/s43556-025-00358-4

Verify or expand the search:

Other recruiting trials for Oral Mucositis

Currently open trials in the same condition.

NCT07491536 — Ozone Therapy With Biomimetic Oral Care for Cancer-Related Oral Mucositis · NA · recruiting
NCT07400328 — Amimestrocel Injection for Preventing Severe Oral Mucositis in HSCT Patients · Phase 2 · recruiting
NCT06525402 — Effect of Sodium Bicarbonate, Saline and Black Mulberry Syrup on Degree of Oral Mucositis in Children Receiving Chemothe · NA · recruiting
NCT06315855 — F.L.O.S.S. Project (Facilitated Lessons on Oral and Systemic Health in Survivors) · NA · recruiting
NCT05966194 — RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01400620 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Izun Pharma Ltd
Last refreshed: 12 March 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01400620.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing