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

• Sponsor: Indiana University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01317472
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arms: 2
• Duration (Months): 32.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Laryngopharyngeal Reflux	Drug: dexlansoprazole; Drug: Placebo	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-Blinded, Placebo-Controlled Trial to Investigate Dexlansoprazole for the Treatment of Laryngopharyngeal Reflux
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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: Placebo; 1 tablet of placebo QAM (1 hour AC) for 2 months

Outcome Measures

Primary Outcome Measures

1. Change in Reflux Symptom Index (RSI) [Baseline to 2 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• 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 Proton pump inhibitors (PPI) therapy for greater than 2 months without symptomatic relief (with an RSI ≥14)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clarian North Hospital -- IUMG Clinic	Indianapolis	Indiana	United States	46220

Sponsors and Collaborators

• Indiana University

Investigators

• Principal Investigator: Stacey L Halum, MD, Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Indiana University
• ClinicalTrials.gov Identifier: NCT01317472
• Other Study ID Numbers: MSA-NC-DEX-115
• First Posted: Mar 17, 2011
• Last Update Posted: Oct 1, 2019
• Last Verified: Sep 1, 2019

• Keywords provided by Indiana University: laryngopharyngeal reflux, acid reflux, throat reflux
• Additional relevant MeSH terms: Gastroesophageal Reflux; Laryngopharyngeal Reflux; Dexlansoprazole; Lansoprazole

Study Results

Participant Flow

Arm/Group Title	Dexlansoprazole	Sugar Pill
Arm/Group Description	Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC). dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months	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). dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months
Period Title: Overall Study
STARTED	9	2
COMPLETED	7	2
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Dexlansoprazole	Sugar Pill	Total
Arm/Group Description	Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC). dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months	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). dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months	Total of all reporting groups
Overall Participants	9	2	11
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	9 100%	2 100%	11 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	9 100%	2 100%	11 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Change in Reflux Symptom Index (RSI)
Description	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.
Time Frame	Baseline to 2 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexlansoprazole	Sugar Pill
Arm/Group Description	Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC). dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months	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). dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months
Measure Participants	7	2
Mean (Standard Deviation) [units on a scale]	18 (3.95)	13 (4.54)

Adverse Events

Arm/Group Title	Dexlansoprazole		Sugar Pill
Arm/Group Description	Patients who agree to participate in the study will be randomized to receive 60 mg po QAM Kapidex (1 hour AC). dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months		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). dexlansoprazole: 60 mg dexlansoprazole QAM (1 hour AC) for 2 months
All Cause Mortality
	Dexlansoprazole		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/2 (0%)
Serious Adverse Events
	Dexlansoprazole		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Dexlansoprazole		Sugar Pill
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/9 (0%)		0/2 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.