Trial Outcomes & Findings for Inhibition of Gastric Acid is the Key to Satisfactory Relief of Symptoms With Esomeprazole in NUD Patients (NCT NCT00222131)

Results Overview

Dyspeptic symptoms severity will be assessed with validated 7-graded diary cards. The diary cards asked "Please state for each day if you have experienced pain or discomfort in the stomach." Measure taken over 7 consecutive days of a 2 week run in and at the end of each therapeutic period.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

73 participants

Primary outcome timeframe

8 Weeks

Results posted on

2019-11-27

Participant Flow

Participant milestones

Participant milestones
Measure	Esomeprazole Esomeprazole 40 mg one time a day (QD)	Placebo Matching placebo
Overall Study STARTED	38	35
Overall Study COMPLETED	38	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Inhibition of Gastric Acid is the Key to Satisfactory Relief of Symptoms With Esomeprazole in NUD Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Esomeprazole n=38 Participants Esomeprazole 40 mg QD	Placebo n=35 Participants Matching placebo	Total n=73 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	38 Participants n=5 Participants	35 Participants n=7 Participants	73 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants	35 participants n=7 Participants	73 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 Weeks

Dyspeptic symptoms severity will be assessed with validated 7-graded diary cards. The diary cards asked "Please state for each day if you have experienced pain or discomfort in the stomach." Measure taken over 7 consecutive days of a 2 week run in and at the end of each therapeutic period.

Outcome measures

Outcome measures
Measure	Esomeprazole n=38 Participants Esomeprazole 40 mg QD	Placebo n=35 Participants Matching placebo
Percentage of Participants With Satisfactory Relief of Non-ulcer Dyspepsia Symptoms 4 Weeks	71 percentage of participants	34 percentage of participants
Percentage of Participants With Satisfactory Relief of Non-ulcer Dyspepsia Symptoms 8 Weeks	82 percentage of participants	56 percentage of participants

SECONDARY outcome

Timeframe: 8 Weeks

Time (minutes) gastric pH remained \>4.0 during 24-hours gastric pH monitoring.

Outcome measures

Outcome measures
Measure	Esomeprazole n=38 Participants Esomeprazole 40 mg QD	Placebo n=35 Participants Matching placebo
Satisfactory Relief of Non-ulcer Dyspepsia Symptoms as Time Gastric pH Remained > 4.0 Within 24 Hours 4 Weeks	1170 minutes Standard Error 51.6	905 minutes Standard Error 134.8
Satisfactory Relief of Non-ulcer Dyspepsia Symptoms as Time Gastric pH Remained > 4.0 Within 24 Hours 8 Weeks	1050 minutes Standard Error 74.3	762 minutes Standard Error 101.8

Adverse Events

Esomeprazole

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Jerzy Sarosiek, MD, PhD, AGAF, FACG

Texas Tech

Phone: 915-215-5255

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place