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

NCT00222131 | Completed Phase 2 Results

• 1 other identifier: 8777
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Inhibition of gastric acid is the key to satisfactory relief of symptoms with esomeprazole in NUD patients

Conditions

Indigestion

Keywords

Epigastric Pain; Non-Ulcer Dyspepsia (NUD)

Outcome Measures

Primary Outcomes (1)

• 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.

  8 Weeks

Secondary Outcomes (1)

• Satisfactory Relief of Non-ulcer Dyspepsia Symptoms as Time Gastric pH Remained > 4.0 Within 24 Hours

  8 Weeks

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo

Other: Placebo

2

ACTIVE COMPARATOR

Esomeprazole

Drug: Esomeprazole

Interventions

Esomeprazole DRUG

Esomeprazole 40 mg QD

Also known as: Nexium

2

Placebo OTHER

Placebo

1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• AstraZeneca: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Dyspepsia

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Jerzy Sarosiek, MD, PhD, AGAF, FACG
• Organization: Texas Tech

jerzy.sarosiek@ttuhsc.edu

915-215-5255

Study Officials

• Richard Mccallum, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

• Jerzy Sarosiek, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: October 1, 2003
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: November 27, 2019
• Results First Posted: November 27, 2019

Record last verified: 2019-11

Locations

US (1)