Trial Outcomes & Findings for Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease (NCT NCT00215787)

Results Overview

Presence of Laryngopharyngeal reflux was measured by 24 hour pH impedance probe monitor per equipment manufacturer software. Two or more episodes in twenty four hours was considered positive, in accordance with published standards.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

one year

Results posted on

2010-09-22

Participant Flow

Participant milestones

Participant milestones
Measure	Lansoprazole Lansoprazole 30mg BID for one year
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lansoprazole n=20 Participants Lansoprazole 30mg BID for one year
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: one year

Presence of Laryngopharyngeal reflux was measured by 24 hour pH impedance probe monitor per equipment manufacturer software. Two or more episodes in twenty four hours was considered positive, in accordance with published standards.

Outcome measures

Outcome measures
Measure	Lansoprazole n=20 Participants Lansoprazole 30mg BID for one year
Presence of Reflux in Patients With Polyposis	15 participants

Adverse Events

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

Scott Phillips

Head and Neck Surgery Associates

Phone: 317-926-1056

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place