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| Sponsor: | Medical College of Wisconsin |
|---|---|
| Collaborators: |
Ortho-McNeil, Inc. Eisai Inc. |
| Information provided by: | Medical College of Wisconsin |
| ClinicalTrials.gov Identifier: | NCT00199953 |
Purpose
Objectives of this study are:
| Condition | Intervention | Phase |
|---|---|---|
|
- Postnasal Drainage |
Drug: Rabeprazole 20 mg twice a day for 90-day period treatment |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Diagnostic |
| Official Title: | Post-Nasal Drainage as an Extraesophageal Manifestation of Reflux |
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2002 |
| Estimated Study Completion Date: | March 2005 |
Gastroesophageal reflux disease(GERD) is a common disorder of the esophagus, affecting 7-10% of the U.S. population. Characteristicx symptoms include heartburn, chest pain, and indigestion. EER denotes gastroesophageal refluxate that reaches structures above the upper esophageal sphincter. EER has been implicated in the pathogenesis of several otolaryngologic disorders such as chronic posterior laryngitis, laryngeal contact ulcer or granuloma, paroxysmal laryngospasm, vocal cord nodules, Reinke's edema, subglottic or laryngotracheal stenosis, globus pharyngeus,and laryngeal and hypopharyngeal carcinoma. In addition, EER has been associated with disorders of both the lower and upper respiratory tract and with chronic sinonasal inflammation.
Patients with EER rarely complain of the common symptoms of GERD, such as heartburn. Often they present with symptoms involving the larynx and pharynx, including throat-clearing, globus pharyngeus, and postnasal drainage. These symptoms may be present due to direct irritation of the nasal epithelium by gastric refluxate and/or a neurogenic inflammatory process mediated by the autonomic nervous system.
Specific Aims:
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Principal Investigator: | Todd A Loehrl, MD | Medical College of Wisconsin |
More Information
| ClinicalTrials.gov Identifier: | NCT00199953 History of Changes |
| Other Study ID Numbers: | RAB-USA-57, IRB numbers:, FMLH # 02-033, HRRC # 056-02 |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 12, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Postnasal drainage Extraesophageal reflux |
|
Rabeprazole Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses |