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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00222079 |
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Date of registration:
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16/09/2005 |
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Primary sponsor: |
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Public title:
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Evaluation of Esomeprazole in Treating Gastro-Esophageal Reflux Disease (GERD) in Head and Neck Cancer Patients Exposed to Radiation Therapy
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Scientific title:
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Pilot Study to Evaluate Esomeprazole (Nexium) in Treating Gastro-Esophageal Reflux in Patients With Head and Neck Cancer With Prior External Beam Radiation Therapy: a Randomized, Prospective, Placebo-Controlled, Double-Blind Study. |
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Date of first enrolment:
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November 2004 |
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Target sample size:
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46 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00222079 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Chad I Hines, BS |
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Address:
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Telephone:
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319-384-7090 |
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Email:
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chad-hines@uiowa.edu |
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Affiliation:
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Name:
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Douglas K trask, MD. Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Iowa |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Signed informed consent
2. History of head and neck cancer
3. Radiation Therapy (external beam or IMRT)
1. Must have received equal or greater than 5000 cGy cumulative dose
2. Must have complaint of xerostomia
3. Greater than three month interval since radiation treatment
Exclusion Criteria:
1. Subjects unable to tolerate pH-probe in past
2. Subjects currently on proton-pump inhibitor (PPI) or H-2 receptor antagonist therapy
3. Prior history of esophago-gastric surgery
4. Symptoms of gastrointestinal bleeding (melena, hematemesis)
5. Known hepatic cirrhosis or esophageal varices
6. Prior esophageal perforation
7. Pregnant, nursing or not likely to be using adequate contraceptive measures
8. Subjects not predicted to survive duration of study
9. Subjects with allergies or sensitivities to proton-pump inhibitors
10. Psychological, familial, sociological or geographical conditions which do not permit
Study follow-up and compliance with study protocol
11. Subjects predicted to undergo surgery, chemotherapy or radiation therapy for head and
neck cancer during the course of study
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Gastro-Esophageal Reflux
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Intervention(s)
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Drug: Esomeprazole (Nexium)
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Secondary ID(s)
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200308067
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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