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Sponsors and Collaborators: |
University of Connecticut National Institutes of Health (NIH) Pfizer |
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Information provided by: | University of Connecticut |
ClinicalTrials.gov Identifier: | NCT00698204 |
Oral mucositis refers to ulcerative lesions of the oral mucosa that occur due to radiation therapy given for treatment of head and neck cancer. These lesions are painful, compromise nutrition and quality of life and may necessitate interruptions in radiation therapy, thus adversely affecting cancer therapy outcomes. This study will examine the use of an anti-inflammatory medicine to reduce pain and severity of oral mucositis.
Condition | Intervention | Phase |
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Oral Mucositis |
Drug: celecoxib Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Cyclooxygenase-2 Inhibition in Radiation-Induced Oral Mucositis |
Estimated Enrollment: | 40 |
Study Start Date: | July 2003 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I- Celecoxib: Experimental |
Drug: celecoxib
Subject will be asked to take celecoxib each day that radiation therapy is given.
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II: Placebo Comparator |
Drug: placebo
Subject will be asked to take placebo each day that radiation therapy is given.
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
Contact: Linda Choquette, RDH, CCRP | 860-679-3918 | choquette@uchc.edu |
United States, Connecticut | |
University of Connecticut Health Center | Recruiting |
Farmington, Connecticut, United States, 06030-1605 | |
Sub-Investigator: Robert J Dowsett, MD | |
Sub-Investigator: Upendra Hegde, MD | |
Sub-Investigator: Carol E Pilbeam, MD | |
Sub-Investigator: Stephen T Sonis, DMD, DMSc | |
Sub-Investigator: Khamis Abu-Hasaballah, Ph.D |
Principal Investigator: | Rajesh V Lalla, DDS, Ph.D, CCRP | University of Connecticut Health Center |
Principal Investigator: | Douglas E Peterson, DMD, Ph.D | University of Connecticut Health Center |
Responsible Party: | University of Connecticut Health Center ( Rajesh V. Lalla, DDS, Ph.D, CCRP and Douglas E. Peterson DMD, Ph.D ) |
Study ID Numbers: | IRB 03 -157- 2, GCRC 487, Pfizer, Inc.: COXAON-0509-150 |
Study First Received: | June 12, 2008 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00698204 |
Health Authority: | United States: Institutional Review Board |
Mucositis Head and Neck Cancer Head and Neck Neoplasms Stomatitis |
Mouth Diseases Celecoxib Digestive System Diseases Stomatitis Mucositis |
Gastrointestinal Diseases Head and Neck Neoplasms Stomatognathic Diseases Gastroenteritis |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Enzyme Inhibitors Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |