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

• Sponsor: University of Kansas Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00637416
• Collaborator: TAP Pharmaceutical Products Inc. (Industry)
• Enrollment: 9
• Location: 1
• Arms: 2
• Duration (Months): 16
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dysphonia	Drug: Lansoprazole; Other: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 9 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Effect of Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lansoprazole and dietary control Lansoprazole and dietary control	Drug: Lansoprazole; Lansoprazole 30 mg taken by mouth daily for 3 months; Other Names: Prevacid
Placebo Comparator: Placebo and dietary control Dietary control and placebo	Other: Placebo; placebo taken by mouth daily for 3 months

Outcome Measures

Primary Outcome Measures

1. Change in Condition Over Treatment Period [3 months]

   Change measured using voice assessment protocol-Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

• University of Kansas Medical Center
• TAP Pharmaceutical Products Inc.

Investigators

• Principal Investigator: Julie Wei, University of Kansas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT00637416
• Other Study ID Numbers: 10720
• First Posted: Mar 18, 2008
• Last Update Posted: Jan 23, 2017
• Last Verified: Nov 1, 2016

• Keywords provided by University of Kansas Medical Center: horseness
• Additional relevant MeSH terms: Dysphonia; Hoarseness; Lansoprazole; Dexlansoprazole

Study Results

Participant Flow

Arm/Group Title	Lansoprazole and Dietary Control	Placebo and Dietary Control
Arm/Group Description	Lansoprazole and dietary control Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months	Dietary control and placebo Placebo: placebo taken by mouth daily for 3 months
Period Title: Overall Study
STARTED	4	5
COMPLETED	3	3
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Lansoprazole and Dietary Control	Placebo and Dietary Control	Total
Arm/Group Description	Lansoprazole and dietary control Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months	Dietary control and placebo Placebo: placebo taken by mouth daily for 3 months	Total of all reporting groups
Overall Participants	4	5	9
Age (Count of Participants)
<=18 years	4 100%	5 100%	9 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Gender (Count of Participants)
Female	2 50%	2 40%	4 44.4%
Male	2 50%	3 60%	5 55.6%
Region of Enrollment (participants) [Number]
United States	4 100%	5 100%	9 100%

Outcome Measures

1. Primary Outcome

Title	Change in Condition Over Treatment Period
Description	Change measured using voice assessment protocol-Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS).
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Study was stopped early, data were not collected, and zero participants were analyzed.

Arm/Group Title	Lansoprazole and Dietary Control	Placebo and Dietary Control
Arm/Group Description	Lansoprazole and dietary control Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months	Dietary control and placebo Placebo: placebo taken by mouth daily for 3 months
Measure Participants	0	0

Adverse Events

Arm/Group Title	Lansoprazole and Dietary Control		Placebo and Dietary Control
Arm/Group Description	Lansoprazole and dietary control Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months		Dietary control and placebo Placebo: placebo taken by mouth daily for 3 months
All Cause Mortality
	Lansoprazole and Dietary Control		Placebo and Dietary Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Lansoprazole and Dietary Control		Placebo and Dietary Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Lansoprazole and Dietary Control		Placebo and Dietary Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/5 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.