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

NCT01317472 | Terminated Results DMC

• 1 other identifier: MSA-NC-DEX-115
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Laryngopharyngeal Reflux

Keywords

laryngopharyngeal reflux, acid reflux, throat reflux

Outcome Measures

Primary Outcomes (1)

• Change in Reflux Symptom Index (RSI)

  The Reflux Symptom Index (RSI) is a 9-item measure with each symptom rated from 0 (no problem) to 5 (severe problem), for a total possible range of 0 (no problem) to 45 (severe problem). An RSI of \>13 is considered to be abnormal.

  Baseline to 2 months

Study Arms (2)

Dexlansoprazole

EXPERIMENTAL

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

Drug: dexlansoprazole

Sugar pill

PLACEBO COMPARATOR

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: Placebo

Interventions

dexlansoprazole DRUG

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

Also known as: Dexilant

Dexlansoprazole

Placebo DRUG

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

Sugar pill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Clarian North Hospital -- IUMG Clinic

Indianapolis, Indiana, 46220, United States

Location

MeSH Terms

Conditions

Laryngopharyngeal Reflux; Gastroesophageal Reflux

Interventions

Dexlansoprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Lansoprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

very poor recruitment. patients were not willing to enter study because they did not want to take a chance on receiving placebo.

Results Point of Contact

• Title: Terese Stevens, Dept administrator
• Organization: Indiana University

tstevens@iupui.edu

317-278-3187

Study Officials

• Stacey L Halum, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2011
• First Posted: March 17, 2011
• Study Start: March 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: October 1, 2019
• Results First Posted: October 1, 2019

Record last verified: 2019-09

Locations

US (1)