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

NCT ID: NCT01317472

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-11-30

Brief Summary

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 laryngopharyngeal reflux (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.

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.

Conditions

Laryngopharyngeal Reflux

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dexlansoprazole

Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC).

Group Type: EXPERIMENTAL

dexlansoprazole

Intervention Type: DRUG

60 mg dexlansoprazole QAM (1 hour AC) for 2 months

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).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1 tablet of placebo QAM (1 hour AC) for 2 months

Interventions

dexlansoprazole

60 mg dexlansoprazole QAM (1 hour AC) for 2 months

Intervention Type: DRUG

Placebo

1 tablet of placebo QAM (1 hour AC) for 2 months

Intervention Type: DRUG

Other Intervention Names

Dexilant

Eligibility Criteria

Inclusion 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 Proton pump inhibitors (PPI) therapy for greater than 2 months without symptomatic relief (with an RSI ≥14)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stacey L Halum, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Clarian North Hospital -- IUMG Clinic

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

MSA-NC-DEX-115

Identifier Type: -

Identifier Source: org_study_id