The Effects of Dexlansoprazole for the Treatment of Throat-Related Reflux
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Purpose
Recent studies have demonstrated that patients with throat-related reflux often require twice daily proton pump inhibitor therapy to attain significant symptomatic improvement, with once daily therapy offering little relief. As dexlansoprazole is a twice-daily release proton pump inhibitor requiring only once-daily dosing, it may provide LPR symptomatic relief comparable to that of twice daily dosing, yet be more readily approved by third party payers because of its once daily dosing requirements. It is hypothesized that, in patients with pharyngeal-probe proven throat reflux, there will be significantly greater improvement in symptoms and pharyngeal probe findings in those patients receiving dexlansoprazole than those receiving placebo alone.
| Condition | Intervention |
|---|---|
|
Laryngopharyngeal Reflux |
Drug: dexlansoprazole |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Double-Blinded, Placebo-Controlled Trial to Investigate Dexlansoprazole for the Treatment of Laryngopharyngeal Reflux |
- Reflux Symptom Index (RSI) [ Time Frame: 2 months ] [ Designated as safety issue: No ]Evaluating the change in the RSI will be a primary endpoint of the study and is anticipated to be significantly different between the study and control groups after two months of treatment with dexlansoprazole versus placebo, respectively.
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dexlansoprazole
Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC).
|
Drug: dexlansoprazole
60 mg dexlansoprazole QAM (1 hour AC) for 2 months
Other Name: Dexilant
|
|
Placebo Comparator: Sugar pill
Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC) or 1 tablet of placebo QAM (1 hour AC).
|
Drug: dexlansoprazole
60 mg dexlansoprazole QAM (1 hour AC) for 2 months
Other Name: Dexilant
|
Detailed Description:
The aim of the study is to compare outcomes, based on RSI-based symptomatic improvement and pharyngeal probe results, after LPR patients are treated for two months with once-daily (QAM) Kapidex versus placebo.Forty patients with pharyngeal pH probe-documented LPR and an elevated reflux symptom index (RSI) (≥14) will be enrolled into a double-blinded placebo controlled study. Twenty patients will receive Kapidex once daily, while twenty receive placebo. Patients will return at two months for evaluation with repeat RSI documentation and repeat pharyngeal pH probe testing. Student t-test will be used to determine if the change in RSI and pH-probe results differs between the study and placebo group.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:patients with an abnormal Restech pH probe study and also have an RSI of 14 or greater will be invited to participate in the study
Exclusion Criteria:known intolerance or allergy to proton pump inhibitors, hypersecretory conditions (Zollinger-Ellison), self-reported anxiety/depression (shown to affect RSI),16 history of laryngeal irradiation, or have been on twice daily PPI therapy for greater than 2 months without symptomatic relief (with an RSI ≥14)
Contacts and Locations| United States, Indiana | |
| Clarian North Hospital -- IUMG Clinic | Recruiting |
| Indianapolis, Indiana, United States, 46220 | |
| Contact: Stacey L Halum, MD 317-688-4824 shalum@iupui.edu | |
| Contact: Heather Hillman, RN 317-688-4864 hhillman@iuhealth.org | |
| Principal Investigator: Stacey L Halum, MD | |
| Principal Investigator: | Stacey L Halum, MD | Indiana University |
More Information
No publications provided
| Responsible Party: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT01317472 History of Changes |
| Other Study ID Numbers: | MSA-NC-DEX-115 |
| Study First Received: | March 16, 2011 |
| Last Updated: | March 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Indiana University:
|
laryngopharyngeal reflux, acid reflux, throat reflux |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Regurgitation, Gastric Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Lansoprazole |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013