Efficacy, Safety and Tolerability of AG013 in Oral Mucositis Compared to Placebo When Administered Three Times Per Day
Public ClinicalTrials.gov record NCT03234465. 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 Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Topically-applied AG013 for the Attenuation of Oral Mucositis in Subjects With Cancers of the Head and Neck Receiving Concomitant Chemoradiation Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study is to evaluate the efficacy, safety and tolerability of topically administered AG013 compared to placebo for reducing Oral Mucositis (OM) in patients undergoing chemoradiation for the treatment of head and neck cancer, as measured by the duration, time to development, and overall incidence of OM during the active treatment phase, beginning from the start of chemoradiation therapy (CRT) until 2 weeks following its completion. The effect of AG013 on patient-reported symptoms and analgesic use during the active treatment phase, and on the cumulative radiation dose administered before the onset of OM will also be evaluated, as will biomarkers and, in a subset of subjects, the PK (pharmacokinetic) profile of AG013.
Study identification
- NCT ID
- NCT03234465
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 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
- Jul 18, 2017 (Actual)
- Primary completion
- Mar 31, 2020 (Actual)
- Completion
- Jul 13, 2020 (Actual)
- Last update posted
- Nov 23, 2020
2017 – 2020
United States locations
- U.S. sites
- 27
- U.S. states
- 18
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Connecticut Health Center | Farmington | Connecticut | 06030 | — |
| Helen F. Graham Cancer Center | Newark | Delaware | 19713 | — |
| UF Health Cancer Center | Orlando | Florida | 32806 | — |
| Columbus Regional Research Institute | Columbus | Georgia | 31904 | — |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | — |
| St. Vincent Anderson Regional, Cancer Center | Anderson | Indiana | 46016 | — |
| Norton Cancer Institute, Multicisciplinary Clinic | Louisville | Kentucky | 40202 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| Willis-Knighton Cancer Center | Shreveport | Louisiana | 71103 | — |
| University of Michigan | Ann Arbor | Michigan | 48109-5008 | — |
| Comprehensive Cancer Centers of Nevada-Henderson | Henderson | Nevada | 89052 | — |
| Renown Regional Medical Center | Reno | Nevada | 89502 | — |
| Northwell Health Cancer Institute / Center for Novel Cancer Therapeutics | Lake Success | New York | 11042 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Montefiore Medical Center, Albert Einstein College of Medicine, Department of Radiation Oncology | The Bronx | New York | 10467 | — |
| Caromont Regional Medical Center | Gastonia | North Carolina | 28054 | — |
| East Carolina Univ School of Dental Medicine | Greenville | North Carolina | 27834-4354 | — |
| Mercy Medical Center | Canton | Ohio | 44708 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Temple University Hospital, Radiation Oncology | Philadelphia | Pennsylvania | 19140 | — |
| UPMC Shadyside Hospital | Pittsburgh | Pennsylvania | 15232 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Huntsman Cancer Hospital | Salt Lake City | Utah | 84112 | — |
| Radiation Oncology Moser | Charlottesville | Virginia | 22903 | — |
| PeaceHealth St. Joseph Medical Center | Bellingham | Washington | 98225 | — |
| Multicare Health Center | Gig Harbor | Washington | 98405 | — |
| Cancer Care NW | Spokane | Washington | 99216 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03234465, 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 Nov 23, 2020 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03234465 live on ClinicalTrials.gov.