Trial Outcomes & Findings for Twenty-Four Hour Combined Multi-Channel Impedance and pH Ambulatory Monitoring: Impedance Reflux Episodes of Patients On and Off Proton Pump Inhibitor Therapy (NCT NCT01710800)

Results Overview

Impedance is defined as a 50% decrease from baseline in retrograde movement of liquid from the stomach to the esophagus. In other words, it measures the number of retrograde reflux episodes.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

41 participants

Primary outcome timeframe

1 week

Results posted on

2013-01-09

Participant Flow

All eligible patients with suspected GERD will be referred to the manometry and reflux lab testing for potential recruitment into the study

Prior to undergoing 24 hour pH with impedance, all participants will receive either one week of esomeprazole or one week of placebo.

Participant milestones

Participant milestones
Measure	First Intervention (7 Days), Second Intervention (7 Days) Patients will be randomized to receive either PPI or placebo (sequence 1) for 7 days and then undergo a 24 hour pH study with impedance to measure the number of reflux episode. The second sequence of medications (that is either placebo or PPI or sequence 2) will be administered followed by repeat 24 hour pH with impedance 7 days later.
Overall Study STARTED	63
Overall Study Received PPI Intervention	44
Overall Study Received Placebo Intervention	45
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Reasons for withdrawal
Measure	First Intervention (7 Days), Second Intervention (7 Days) Patients will be randomized to receive either PPI or placebo (sequence 1) for 7 days and then undergo a 24 hour pH study with impedance to measure the number of reflux episode. The second sequence of medications (that is either placebo or PPI or sequence 2) will be administered followed by repeat 24 hour pH with impedance 7 days later.
Overall Study Withdrawal by Subject	21
Overall Study Protocol Violation	1

Baseline Characteristics

Twenty-Four Hour Combined Multi-Channel Impedance and pH Ambulatory Monitoring: Impedance Reflux Episodes of Patients On and Off Proton Pump Inhibitor Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=41 Participants Patients will be randomized to receive either PPI or placebo (sequence 1) and then undergo a 24 hour pH study with impedance to measure the number of reflux episodes. Sequence 2 (placebo or PPI) will be administered followed by repeat 24 hour pH with impedance.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	52 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Population: We analyzed as per protocol. Only patients who completed both 24 hour pH studies with impedance were analyzed.

Impedance is defined as a 50% decrease from baseline in retrograde movement of liquid from the stomach to the esophagus. In other words, it measures the number of retrograde reflux episodes.

Outcome measures

Outcome measures
Measure	Placebo Arm n=41 Participants Patients will be randomized to receive either PPI or placebo and then undergo a 24 hour pH study with impedance to measure the number of reflux episodes	Esomeprazole n=41 Participants Patients were randomly assigned to receive 40 mg esomeprazole twice daily prior to undergoing a 24 hour pH study with impedance to measure the number of reflux episodes
Number of Impedance Episodes Following PPI and Placebo	47 number of episodes Standard Deviation 22	53 number of episodes Standard Deviation 29

Adverse Events

Placebo Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PPI Arm

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. Fouad J. Moawad

Walter Reed National Military Medical Center

Phone: (301) 400-1551

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place