Indigestion
Conditions
Keywords
Epigastric Pain, Non-Ulcer Dyspepsia (NUD)
Brief summary
Inhibition of gastric acid is the key to satisfactory relief of symptoms with esomeprazole in NUD patients
Detailed description
Enrolled patients will undergo 24h gastric pH monitoring and subsequently (if gastric pH drops below pH 4 during 24h monitoring) will be randomized to receive placebo (40 mg QD) or esomeprazole (40 mg QD) for 16 weeks of therapy. 24h gastric pH monitoring will be repeated 2nd and 3rd time in all participating patients at the end of 4th and 8th weeks of therapy. Additionally, in all participants NUD symptoms will be re-assessed at the end of 4th, 8th, 12th and 16th weeks of therapy.
Interventions
DRUGEsomeprazole
Esomeprazole 40 mg QD
OTHERPlacebo
Placebo
Sponsors
AstraZeneca
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
A. Males and females of age 18-55. B. A diagnosis of epigastric pain/discomfort (located in the upper abdomen) rated by the patient as moderate to severe in intensity (on a four-point categorical scale), which has been present at least 3 times per week for 12 weeks, unrelated to exercise. C. Patients may have other symptoms of NUD including heartburn, regurgitation, bloating (abdominal distension), early satiety (feeling of fullness), belching (burping), or nausea; however, the dominant symptom must be epigastric pain/discomfort. D. Capable of and willing to give informed consent and comply with all study requirements.
Exclusion criteria
A. H. pylori positive serology. B. Regular use of NSAIDs or more than 100 mg of aspirin. C. Patients requiring chronic treatment with any medication inducing GI symptoms (e.g., certain antibiotics, codeine, etc.). D. History or presence of endoscopic/radiological evidence of esophagitis. E. History or presence of chronic gastric or duodenal ulcer. F. History or presence of duodenal erosions. G. History or previous upper GI surgery. H. Presence of concomitant symptoms of irritable bowel syndrome (IBS) as assessed by three or more of the Manning or Rome criteria. I. History or presence of other known organic disease that might explain the dyspepsia symptoms (e.g., symptomatic gallstones). J. Pregnancy or lactation. K. Inadequate contraception. L. Regular consumption of greater than 2 fluid ounces of beverage alcohol (corresponding to 2 cocktails or 40 fluid ounces of beer or 16 fluid ounces of wine) per day. M. History of substance abuse. N. Unwillingness or expected inability to tolerate absence of antisecretory medications (antacids, H2 receptor antagonists or Proton pump inhibitors (PPIs) or other GI pharmacotherapy for a period of time of study protocol (16 weeks maximum).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Satisfactory Relief of Non-ulcer Dyspepsia Symptoms | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfactory Relief of Non-ulcer Dyspepsia Symptoms as Time Gastric pH Remained > 4.0 Within 24 Hours | 8 Weeks | Time (minutes) gastric pH remained \>4.0 during 24-hours gastric pH monitoring. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Esomeprazole Esomeprazole 40 mg QD | 38 |
| Placebo Matching placebo | 35 |
| Total | 73 |
Baseline characteristics
| Characteristic | Esomeprazole | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants | 35 Participants | 73 Participants |
| Region of Enrollment United States | 38 participants | 35 participants | 73 participants |
| Sex: Female, Male Female | 21 Participants | 20 Participants | 41 Participants |
| Sex: Female, Male Male | 17 Participants | 15 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 35 |
| other Total, other adverse events | 0 / 38 | 0 / 35 |
| serious Total, serious adverse events | 0 / 38 | 0 / 35 |
Outcome results
Primary
Percentage of Participants With Satisfactory Relief of Non-ulcer Dyspepsia Symptoms
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.
Time frame: 8 Weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Esomeprazole | Percentage of Participants With Satisfactory Relief of Non-ulcer Dyspepsia Symptoms | 4 Weeks | 71 percentage of participants |
| Esomeprazole | Percentage of Participants With Satisfactory Relief of Non-ulcer Dyspepsia Symptoms | 8 Weeks | 82 percentage of participants |
| Placebo | Percentage of Participants With Satisfactory Relief of Non-ulcer Dyspepsia Symptoms | 4 Weeks | 34 percentage of participants |
| Placebo | Percentage of Participants With Satisfactory Relief of Non-ulcer Dyspepsia Symptoms | 8 Weeks | 56 percentage of participants |
Secondary
Satisfactory Relief of Non-ulcer Dyspepsia Symptoms as Time Gastric pH Remained > 4.0 Within 24 Hours
Time (minutes) gastric pH remained \>4.0 during 24-hours gastric pH monitoring.
Time frame: 8 Weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Esomeprazole | 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 |
| Esomeprazole | 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 |
| Placebo | Satisfactory Relief of Non-ulcer Dyspepsia Symptoms as Time Gastric pH Remained > 4.0 Within 24 Hours | 4 Weeks | 905 minutes | Standard Error 134.8 |
| Placebo | Satisfactory Relief of Non-ulcer Dyspepsia Symptoms as Time Gastric pH Remained > 4.0 Within 24 Hours | 8 Weeks | 762 minutes | Standard Error 101.8 |