Trial Outcomes & Findings for Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness (NCT NCT00637416)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

9 participants

Primary outcome timeframe

3 months

Results posted on

2017-01-23

Participant milestones
Measure	Lansoprazole and Dietary Control Lansoprazole and dietary control Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months	Placebo and Dietary Control Dietary control and placebo Placebo: placebo taken by mouth daily for 3 months
Overall Study STARTED	4	5
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal
Measure	Lansoprazole and Dietary Control Lansoprazole and dietary control Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months	Placebo and Dietary Control Dietary control and placebo Placebo: placebo taken by mouth daily for 3 months
Overall Study Lost to Follow-up	1	1
Overall Study Unable to take study drug	0	1

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

Baseline characteristics by cohort
Measure	Lansoprazole and Dietary Control n=4 Participants Lansoprazole and dietary control Lansoprazole: Lansoprazole 30 mg taken by mouth daily for 3 months	Placebo and Dietary Control n=5 Participants Dietary control and placebo Placebo: placebo taken by mouth daily for 3 months	Total n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Gender Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Gender Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants

Timeframe: 3 months

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

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

Outcome data not reported

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Kansas Medical Center

Phone: (913) 588-7154