NCT02542215

Cobiprostone for the Prevention of Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concurrent Radiation and Chemotherapy

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Sucampo Pharma Americas, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Treatment for head and neck cancer often involves a combination of chemotherapy and radiation. One of the unfortunate consequences of standard care for head and neck cancer is the development of painful mouth sores, known as oral mucositis. This study will evaluate the use of cobiprostone spray to prevent oral mucositis, when given for the duration of radiation and chemotherapy (RT/CT) standard care.

Conditions

• Oral Mucositis

Interventions

Type	Name	Description
DRUG	Cobiprostone	Cobiprostone 30 mcg oral spray
DRUG	Placebo	Matching placebo oral spray
DRUG	Standard Care - Chemotherapy	Chemotherapy, as given with radiation as standard care for patients with head and neck cancer.
RADIATION	Standard Care - Radiation	Radiation, as given with chemotherapy as standard care for patients with head and neck cancer.

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-09-04
• Last updated: 2019-12-02

Locations

76 sites across 1 country: United States