Study to Determine the Effects Treatment With Amlexanox 0.5% Oral Rinse Solution on Oral Mucositis Associated With Radiation Therapy for Cancer of the Head and Neck Region
Public ClinicalTrials.gov record NCT01083875. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-blind, Randomized, Vehicle-controlled Phase II Study to Determine the Effects of Concomitant Treatment With Amlexanox 0.5% Oral Rinse Solution on Oral Mucositis Associated With Radiation Therapy for Cancer of the Head and Neck Region
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study was to determine the effect of 0.5% amlexanox oral rinse compared to a vehicle control on mucositis-related ulceration and erythema (objective score)and on mucositis-related oral pain (subjective score). A secondary objective was to evaluate the safety of 0.5% amlexanox oral rinse by determining the frequency of treatment-emergent drug-related adverse events or clinical laboratory abnormalities.
Study identification
- NCT ID
- NCT01083875
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 58 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2000 (Type not available)
- Primary completion
- Not listed
- Completion
- Jun 2001 (Actual)
- Last update posted
- Mar 18, 2010
2000 – 2001
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mobile Infirmary Medical Center | Mobile | Alabama | 36607 | — |
| University of Arkansas Medical School | Little Rock | Arkansas | 72205 | — |
| Florence Wheeler Cancer Center | Bakersfield | California | 93301 | — |
| University of Connecticut Health Center | Farmington | Connecticut | 06030 | — |
| ICSL Clinical Studies | Melbourne | Florida | 32935 | — |
| Loyola University Medical Center | Maywood | Illinois | 60115 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Wayne State University School of Medicine | Detroit | Michigan | 48201 | — |
| University of Tennessee | Memphis | Tennessee | 38163 | — |
| St. Thomas Hospital | Nashville | Tennessee | 37202 | — |
| Arlington Cancer Center | Arlington | Texas | 76012 | — |
| Corpus Christi Cancer Center | Corpus Christi | Texas | 78412 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01083875, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 18, 2010 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01083875 live on ClinicalTrials.gov.