NCT01083875

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2000

Shorter than P25 for phase_2

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2001

Completed
8.8 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2010

Completed
Last Updated

March 18, 2010

Status Verified

March 1, 2010

First QC Date

March 8, 2010

Last Update Submit

March 16, 2010

Conditions

Oral Mucositis

Keywords

Radiationmucositishead and neck carcinomaoral rinseamlexanoxMuGard

Outcome Measures

Primary Outcomes (1)

  • Evaluation of mucositis using the Oral Mucositis Assessment Score

    7 weeks

Secondary Outcomes (1)

  • Frequency of treatment-emergent, drug-related Serious Adverse Events

    7 weeks

Study Arms (2)

0.5% amlexanox oral rinse

EXPERIMENTAL

Patients treated with an oral rinse containing the active 0.5% amlexanox

Drug: amlexanox

Vehicle

PLACEBO COMPARATOR

Patients treated with an oral rinse containing no active

Drug: Vehicle rinse

Interventions

amlexanoxDRUG

0.5% amlexanox oral rinse; use 5 ml every 2-3 hours during the awake hours of each day (a minimum of 6 times each day). The liquid was be swirled around the mouth then to be swallowed. Repeated daily until completion of radiation therapy: approximately 7-8 weeks.

0.5% amlexanox oral rinse
Vehicle rinseDRUG

use 5 ml of the vehicle rinse every 2-3 hours during the awake hours of each day (a minimum of 6 times each day). The liquid is be swirled around the mouth then swallowed.

Also known as: MuGard
Vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is 18 years of age or older;
  • Patient has a histologically documented diagnosis of cancer of the head and neck region;
  • Patient is about to receive a course of radiation therapy (with or without concomitant chemotherapy) with a planned dose of at least 60 Gy over 6-7 weeks, and with planned fields to involve at least 50% of the oral mucosa;
  • This criterion was amended (Amendment 01 dated August 28, 2000) to read as follows:
  • \. Amended: Patient is at a high risk of developing radiation-induced mucositis. For the purpose of this study, high-risk patients will be defined as:
  • patients about to receive a course of radiation therapy (with or without concomitant chemotherapy) with a planned dose of at least 60 Gy over 6-7 weeks, and
  • with planned fields to involve at least 40% of the oral and oropharyngeal mucosa visible by direct inspection;
  • \. Patient has a Karnofsky Performance Scale (KPS) score of 60% or more;
  • \. Patient is willing and able to cooperate with the protocol including rinsing of the oral cavity with the investigational or vehicle oral rinse 6 times per day.
  • \. The patient or guardian is capable of providing informed consent.
  • \. If female, the subject has undergone a urine pregnancy test with negative results, and has agreed to practice effective methods of contraception for the duration of the study.

You may not qualify if:

  • Patient has had previous radiation therapy to the oral mucosa;
  • Patient is about to receive hyperfractionated radiation therapy;
  • Patient has active oral H. simplex lesions, oral candidiasis, or oral mucositis due to other disease processes;
  • Patient has uncontrolled infection;
  • Patient has HIV, Hepatitis B (HBV) (as measured by HBs-Ag) or Hepatitis C (HCV) infection;
  • Patient has not recovered from oral toxicity attributable to prior treatment;
  • Patient has abnormal laboratory values that meet the following criteria:
  • Serum creatinine greater than 2 x upper limit of normal
  • Total bilirubin greater than 3 x upper limit of normal;
  • SGOT greater than 3 x upper limit of normal;
  • LDH greater than 3 x upper limit of normal;
  • Patient has known sensitivities to any of the study preparation ingredients;
  • Patient has participated in a clinical research study within the last 30 days prior to enrollment;
  • Patient is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or other reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Mobile Infirmary Medical Center

Mobile, Alabama, 36607, United States

Location

University of Arkansas Medical School

Little Rock, Arkansas, 72205, United States

Location

Florence Wheeler Cancer Center

Bakersfield, California, 93301, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

ICSL Clinical Studies

Melbourne, Florida, 32935, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Wayne State University School of Medicine

Detroit, Michigan, 48201, United States

Location

University of Tennessee

Memphis, Tennessee, 38163, United States

Location

St. Thomas Hospital

Nashville, Tennessee, 37202, United States

Location

Arlington Cancer Center

Arlington, Texas, 76012, United States

Location

Corpus Christi Cancer Center

Corpus Christi, Texas, 78412, United States

Location

MeSH Terms

Conditions

StomatitisMucositis

Interventions

amlexanox

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesGastroenteritisGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Paul Busse, M.D., Ph.D.

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 8, 2010

First Posted

March 10, 2010

Study Start

February 1, 2000

Study Completion

June 1, 2001

Last Updated

March 18, 2010

Record last verified: 2010-03

Locations

US(12)