Trial Outcomes & Findings for Do Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux Predict Response to Treatment? (NCT NCT00444145)

Results Overview

Dilation of inter cellular spaces (the space within the cell) is reported to be an early morphological (structure and form) marker in gastro-oesophageal reflux. Using electron microscopy, the distance between epithelial cells is quantified.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

38 participants

Primary outcome timeframe

3 months

Results posted on

2017-03-29

Participant Flow

Participant milestones

Participant milestones
Measure	Patients Receiving Prevacid Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy. Prevacid: 30 mg bid for 3 months Esophageal and Laryngeal Biopsies: repeat egd with biopsy
Overall Study STARTED	38
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients Receiving Prevacid Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy. Prevacid: 30 mg bid for 3 months Esophageal and Laryngeal Biopsies: repeat egd with biopsy
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	1
Overall Study non-compliant	11
Overall Study Screen Failures	5

Baseline Characteristics

Do Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux Predict Response to Treatment?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients Receiving Prevacid n=38 Participants Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy. Prevacid: 30 mg bid for 3 months Esophageal and Laryngeal Biopsies: repeat egd with biopsy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Dilation of inter cellular spaces (the space within the cell) is reported to be an early morphological (structure and form) marker in gastro-oesophageal reflux. Using electron microscopy, the distance between epithelial cells is quantified.

Outcome measures

Outcome measures
Measure	Patients Receiving Prevacid n=19 Participants Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy. Prevacid: 30 mg bid for 3 months Esophageal and Laryngeal Biopsies: repeat egd with biopsy
Number of Patients With Dilation of Intracellular Spaces 3 Months After Therapy	0 participants

Adverse Events

Patients Receiving Prevacid

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

Dr. Michael Vaezi

Vanderbilt University

Phone: 615-322-3739

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place