Cobiprostone for the Prevention of Oral Mucositis in Subjects With Head and Neck Cancer



Status:Recruiting
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:18 - Any
Updated:7/8/2016
Start Date:June 2015
Contact:Shadreck M Mareya
Email:info@sucampo.com
Phone:301-961-3400

Use our guide to learn which trials are right for you!

A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Cobiprostone for the Prevention of Severe Oral Mucositis in Subjects With Head and Neck Cancer (HNC)

To evaluate the efficacy, safety, and pharmacokinetics (PK) of liquid cobiprostone in
preventing oral mucositis, when administered topically to the oral mucosa via spray for the
duration of radiation and chemotherapy (RT/CT).


Inclusion Criteria:

- Recently-diagnosed (within the last 6 months), histologically-documented,
non-metastatic squamous cell carcinoma of the oral cavity and/or oropharynx amenable
to radiotherapy with concurrent chemotherapy as the definitive treatment modality.

- Clinical treatment plan calls for a minimum of 50 Gy cumulative radiation dose
administered via continuous course of external beam irradiation to the oral cavity
and/or oropharynx via intensity-modulated radiation therapy [IMRT] and/or
image-guided radiation therapy [IGRT], combined with conventional or
weekly/tri-weekly cisplatin or carboplatin chemotherapy regimen.

Exclusion Criteria:

- Subject has received prior radiation to the head and neck region (+/- chemotherapy).

- Subject has had any other prior invasive malignancy, unless disease-free for a
minimum of 3 years.

- Subject has metastatic disease (M1) Stage IV-C.

- Subject has a presence of mucosal ulceration or oral mucositis at screening or
develops this prior to randomization, and/or has unhealed wounds remaining from
surgical resection and/or excisional biopsy procedure.

- Subject is using a pre-existing feeding tube for nutritional support at study entry.
We found this trial at
80
sites
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Ashland, KY
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
?
mi
from
Bellingham, WA
Click here to add this to my saved trials
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
?
mi
from
Billings, MT
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Boise, ID
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Burlington, MA
Click here to add this to my saved trials
?
mi
from
Canton, OH
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Cookeville, TN
Click here to add this to my saved trials
?
mi
from
Coos Bay, OR
Click here to add this to my saved trials
?
mi
from
Corvalis, OR
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Duarte, CA
Click here to add this to my saved trials
?
mi
from
East Lansing, MI
Click here to add this to my saved trials
Egg Harbor Township, New Jersey 08234
?
mi
from
Egg Harbor Township, NJ
Click here to add this to my saved trials
?
mi
from
Everett, WA
Click here to add this to my saved trials
?
mi
from
Farmington, CT
Click here to add this to my saved trials
?
mi
from
Fort Belvoir, VA
Click here to add this to my saved trials
?
mi
from
Fort Lauderdale, FL
Click here to add this to my saved trials
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
?
mi
from
Fort Sam Houston, TX
Click here to add this to my saved trials
?
mi
from
Fort Wayne, IN
Click here to add this to my saved trials
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
?
mi
from
Galveston, TX
Click here to add this to my saved trials
?
mi
from
Gastonia, NC
Click here to add this to my saved trials
?
mi
from
Gettysburg, PA
Click here to add this to my saved trials
Greenville, North Carolina 27834
?
mi
from
Greenville, NC
Click here to add this to my saved trials
?
mi
from
Hershey, PA
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Lake Worth, FL
Click here to add this to my saved trials
?
mi
from
Lakeland, FL
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Madison, WI
Click here to add this to my saved trials
?
mi
from
Metairie, LA
Click here to add this to my saved trials
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
?
mi
from
Montebello, CA
Click here to add this to my saved trials
?
mi
from
Morgantown, WV
Click here to add this to my saved trials
Myrtle Beach, South Carolina 29572
?
mi
from
Myrtle Beach, SC
Click here to add this to my saved trials
?
mi
from
Naples, FL
Click here to add this to my saved trials
?
mi
from
Natrona Heights, PA
Click here to add this to my saved trials
New Brunswick, New Jersey 08901
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
?
mi
from
Oceanside, CA
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Pawtucket, RI
Click here to add this to my saved trials
?
mi
from
Peoria, AZ
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Plantation, FL
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
Redondo Beach, California 90277
?
mi
from
Redondo Beach, CA
Click here to add this to my saved trials
?
mi
from
Reno, NV
Click here to add this to my saved trials
?
mi
from
Rochester, NY
Click here to add this to my saved trials
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
?
mi
from
South Bend, IN
Click here to add this to my saved trials
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
State College, Pennsylvania 16801
?
mi
from
State College, PA
Click here to add this to my saved trials
?
mi
from
Stuart, FL
Click here to add this to my saved trials
?
mi
from
Sylvania, OH
Click here to add this to my saved trials
?
mi
from
Temple, TX
Click here to add this to my saved trials
?
mi
from
Topeka, KS
Click here to add this to my saved trials
?
mi
from
Urbana, IL
Click here to add this to my saved trials
?
mi
from
Whittier, CA
Click here to add this to my saved trials
?
mi
from
Winter Haven, FL
Click here to add this to my saved trials
?
mi
from
Yuma, AZ
Click here to add this to my saved trials