Trial Outcomes & Findings for Safety and Efficacy of Lansoprazole 30mg Twice Daily in Treatment of Laryngitis Associated With Gastroesophageal Reflux (NCT NCT00369265)

Last Updated: 2012-08-24

Results Overview

Improvement was measured by score on an arytenoid erythema grading scale assigned by member of research staff and independent observers at 6 weeks

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

18 participants

Primary outcome timeframe

6 weeks

Results posted on

2012-08-24

Participant Flow

Inadequate recruitment during this study; therefore, the study was terminated.

Participant milestones

Participant milestones
Measure	Sugar Pill Placebo for Lansoprazole twice daily	Lansoprazole Lansoprazole 30 mg twice daily
Overall Study STARTED	4	7
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Sugar Pill Placebo for Lansoprazole twice daily	Lansoprazole Lansoprazole 30 mg twice daily
Overall Study Study terminated	4	7

Baseline Characteristics

Safety and Efficacy of Lansoprazole 30mg Twice Daily in Treatment of Laryngitis Associated With Gastroesophageal Reflux

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sugar Pill n=4 Participants Placebo for Lansoprazole twice daily	Lansoprazole n=7 Participants Lansoprazole 30 mg twice daily	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age Continuous	33.0 years STANDARD_DEVIATION 11.56 • n=5 Participants	40.1 years STANDARD_DEVIATION 17.33 • n=7 Participants	37.5 years STANDARD_DEVIATION 15.83 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	7 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: No results to report; Study was terminated

Improvement was measured by score on an arytenoid erythema grading scale assigned by member of research staff and independent observers at 6 weeks

Outcome measures

Outcome data not reported

Adverse Events

Sugar Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lansoprazole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert T. Sataloff, M.D., D.M.A., FACS

Philadelphia ENT Associates

Phone: 215-545-3322

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place