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

NCT00637416 | Terminated Phase 4 Results

• 1 other identifier: 10720
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dysphonia

Keywords

horseness

Outcome Measures

Primary Outcomes (1)

• Change in Condition Over Treatment Period

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

  3 months

Study Arms (2)

Lansoprazole and dietary control

ACTIVE COMPARATOR

Lansoprazole and dietary control

Drug: Lansoprazole

Placebo and dietary control

PLACEBO COMPARATOR

Dietary control and placebo

Other: Placebo

Interventions

Lansoprazole DRUG

Lansoprazole 30 mg taken by mouth daily for 3 months

Also known as: Prevacid

Lansoprazole and dietary control

Placebo OTHER

placebo taken by mouth daily for 3 months

Placebo and dietary control

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• TAP Pharmaceutical Products Inc.: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Dysphonia

Interventions

Lansoprazole

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Director, ENT Clinical Research
• Organization: University of Kansas Medical Center

ksykes@kumc.edu

(913) 588-7154

Study Officials

• Julie Wei

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• 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 10, 2008
• First Posted: March 18, 2008
• Study Start: March 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: January 23, 2017
• Results First Posted: January 23, 2017

Record last verified: 2016-11

Locations

US (1)