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Trial Outcomes & Findings for Symptom Control Satisfaction With Proton Pump Inhibitor Regimen (NCT NCT02623816)

NCT ID: NCT02623816

Last Updated: 2022-10-25

Results Overview

The 15-symptom GSAS questionnaire includes measures of: Gastrointestinal distress, Regurgitation/heartburn and Upper respiratory manifestations. The outcome measures were the number, frequency, and severity of GSAS symptoms reported at 6 weeks. Measures were based on aggregate GSAS scores. Symptom numbers range from 0 to 15. Frequency is based on the total number of reported days of symptomatic episodes in the past week divided by the number of potential symptoms (number reported divided by 15 for GSAS score. The range for frequency score:0 to 7 with higher scores indicative of greater frequency of symptoms. Severity is the average distress score reported by individuals (zero if no symptoms). Symptom distress is based on a 4 point Likert scale (0= not at all, 1=somewhat, 2=quite a bit and 3=very much). The higher the score the worse outcome. .

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

64 participants

Primary outcome timeframe

6 weeks

Results posted on

2022-10-25

Participant Flow

Participant milestones

Participant milestones
Measure
Sub-optimal Dosing
No change will be made to the sub-optimal dosing regimen of omeprazole 20 mg. Rescue antacid use is permitted. Total duration of 10 weeks.
Optimal Dosing
Patients will be administered optimal dosing of Omeprazole 20 mg for 4 weeks starting at week 2. Rescue antacid use is permitted. Total duration of 6 weeks. Optimal Dosing of Omeprazole: Omeprazole 20 mg
Overall Study
STARTED
40
24
Overall Study
COMPLETED
38
22
Overall Study
NOT COMPLETED
2
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Symptom Control Satisfaction With Proton Pump Inhibitor Regimen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sub-optimal Dosing
n=40 Participants
No change will be made to the sub-optimal dosing regimen of omeprazole 20 mg. Rescue antacid use is permitted. Total duration of 6 weeks.
Optimal Dosing
n=24 Participants
Patients will be administered optimal regimen dosing of Omeprazole 20 mg for 4 weeks starting at week 2. Rescue antacid use is permitted. Total duration of 6 weeks. Optimal Dosing of Omeprazole: Omeprazole 20 mg
Total
n=64 Participants
Total of all reporting groups
Age, Continuous
49.9 years
STANDARD_DEVIATION 12.2 • n=5 Participants
52.3 years
STANDARD_DEVIATION 13.4 • n=7 Participants
51.1 years
STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male
Female
23 Participants
n=5 Participants
15 Participants
n=7 Participants
38 Participants
n=5 Participants
Sex: Female, Male
Male
17 Participants
n=5 Participants
9 Participants
n=7 Participants
26 Participants
n=5 Participants
Region of Enrollment
United States
40 Participants
n=5 Participants
24 Participants
n=7 Participants
64 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

The 15-symptom GSAS questionnaire includes measures of: Gastrointestinal distress, Regurgitation/heartburn and Upper respiratory manifestations. The outcome measures were the number, frequency, and severity of GSAS symptoms reported at 6 weeks. Measures were based on aggregate GSAS scores. Symptom numbers range from 0 to 15. Frequency is based on the total number of reported days of symptomatic episodes in the past week divided by the number of potential symptoms (number reported divided by 15 for GSAS score. The range for frequency score:0 to 7 with higher scores indicative of greater frequency of symptoms. Severity is the average distress score reported by individuals (zero if no symptoms). Symptom distress is based on a 4 point Likert scale (0= not at all, 1=somewhat, 2=quite a bit and 3=very much). The higher the score the worse outcome. .

Outcome measures

Outcome measures
Measure
Sub-optimal Dosing
n=40 Participants
Continue Current PPI Dosing
Optimal Dosing
n=24 Participants
Continue Current Optimal PPI dosing
Symptom Frequency and Severity/Distress Scores From Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) (Overall)
GSAS Symptoms Score
8.5 score on a scale
Standard Error 0.7
5.2 score on a scale
Standard Error 0.5
Symptom Frequency and Severity/Distress Scores From Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) (Overall)
GSAS Frequency Score
2.2 score on a scale
Standard Error 0.3
1.0 score on a scale
Standard Error 0.2
Symptom Frequency and Severity/Distress Scores From Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) (Overall)
GSAS Severity Score
1.0 score on a scale
Standard Error 0.1
0.6 score on a scale
Standard Error 0.1

Adverse Events

Sub-optimal Dosing

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Optimal Dosing

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

Nisheet Waghray

MetroHealth Medical Center

Phone: 2167785736

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place