The Effects of Dexlansoprazole for the Treatment of Throat-Related Reflux

This study has been terminated.
(Principal investigator left institution)
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01317472
First received: March 16, 2011
Last updated: November 14, 2013
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • 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.


Enrollment: 11
Study Start Date: March 2011
Study Completion Date: November 2013
Primary Completion Date: November 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317472

Locations
United States, Indiana
Clarian North Hospital -- IUMG Clinic
Indianapolis, Indiana, United States, 46220
Sponsors and Collaborators
Indiana University
Investigators
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: November 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
laryngopharyngeal reflux, acid reflux, throat reflux

Additional relevant MeSH terms:
Gastroesophageal Reflux
Laryngopharyngeal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Dexlansoprazole
Lansoprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014