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Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness

Primary Purpose

Dysphonia

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lansoprazole
Placebo
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphonia focused on measuring horseness

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Healthy children with a diagnosis of dysphonia age 3-18 years.
  2. Dysphonia must be present for at least one month duration.
  3. May have vocal cord nodules present.
  4. Pre-enrollment flexible fiberoptic laryngoscopy must not show any potentially life-threatening cause, including but not limited to laryngeal papillomatosis, congenital glottic webs, vocal cord paralysis, or benign and malignant neoplasms.
  5. Must be able to cooperate with recording of voice for analysis(3 seconds of sustained vowel).
  6. Caregiver must be able to read, write, and understand English.
  7. Patient with history of diagnosed asthma must have their asthma well controlled and treated at the time of enrollment for study.

Exclusion Criteria:

  1. Dysphonia must not be due to a potentially life-threatening cause, such as laryngeal papillomatosis, congenital glottic webs, vocal cord paralysis, or benign and malignant neoplasms. This will be determined by visualization with flexible fiberoptic laryngoscopy.
  2. Dysphonia must not be due to an acute upper respiratory infection.
  3. Must not have been treated with proton pump inhibitor medication in the past 12 months.
  4. Inability of child to cooperate with recording of voice for analysis.
  5. Inability of caregiver to read, write, and understand English.
  6. Mental retardation, cognitive impairment, or developmental delay.
  7. History of allergic reaction of any kind to lansoprazole or any other proton pump inhibitor.

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lansoprazole and dietary control

Placebo and dietary control

Arm Description

Lansoprazole and dietary control

Dietary control and placebo

Outcomes

Primary Outcome Measures

Change in Condition Over Treatment Period
Change measured using voice assessment protocol-Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS).

Secondary Outcome Measures

Full Information

First Posted
March 10, 2008
Last Updated
November 29, 2016
Sponsor
University of Kansas Medical Center
Collaborators
TAP Pharmaceutical Products Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00637416
Brief Title
Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness
Official Title
The Effect of Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
Enrollment challenges
Study Start Date
March 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
TAP Pharmaceutical Products Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will examine whether lansoprazole (Prevacid) and dietary control versus dietary control alone will improve pediatric hoarseness symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphonia
Keywords
horseness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lansoprazole and dietary control
Arm Type
Active Comparator
Arm Description
Lansoprazole and dietary control
Arm Title
Placebo and dietary control
Arm Type
Placebo Comparator
Arm Description
Dietary control and placebo
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Other Intervention Name(s)
Prevacid
Intervention Description
Lansoprazole 30 mg taken by mouth daily for 3 months
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo taken by mouth daily for 3 months
Primary Outcome Measure Information:
Title
Change in Condition Over Treatment Period
Description
Change measured using voice assessment protocol-Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy children with a diagnosis of dysphonia age 3-18 years. Dysphonia must be present for at least one month duration. May have vocal cord nodules present. Pre-enrollment flexible fiberoptic laryngoscopy must not show any potentially life-threatening cause, including but not limited to laryngeal papillomatosis, congenital glottic webs, vocal cord paralysis, or benign and malignant neoplasms. Must be able to cooperate with recording of voice for analysis(3 seconds of sustained vowel). Caregiver must be able to read, write, and understand English. Patient with history of diagnosed asthma must have their asthma well controlled and treated at the time of enrollment for study. Exclusion Criteria: Dysphonia must not be due to a potentially life-threatening cause, such as laryngeal papillomatosis, congenital glottic webs, vocal cord paralysis, or benign and malignant neoplasms. This will be determined by visualization with flexible fiberoptic laryngoscopy. Dysphonia must not be due to an acute upper respiratory infection. Must not have been treated with proton pump inhibitor medication in the past 12 months. Inability of child to cooperate with recording of voice for analysis. Inability of caregiver to read, write, and understand English. Mental retardation, cognitive impairment, or developmental delay. History of allergic reaction of any kind to lansoprazole or any other proton pump inhibitor.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Wei
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

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Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness

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