Gastroesophageal Reflux Disease (GERD)/Nighttime Heartburn and Driving Performance

NCT01079884 | Completed

• 2 other identifiers: IRUSESOM043808-03-FB-0036
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The implications of sleep as it relates to the physiology and pathogenesis of a number of diseases has until recently been ignored. With the evolution of sleep laboratories, there is an emerging recognition of the relationship between sleep and various gastrointestinal diseases- in particular gastroesophageal reflux disease (GERD).( 1-5) It seems intuitive that waking/daytime activities or events may affect sleep and that any consequent sleep dysfunction may reciprocally further affect daytime function

Conditions

GERD

Outcome Measures

Primary Outcomes (1)

• Driving impairment effects measured by the driving simulator (variance of 1.5 feet is abnormal).

  All parameters will be assessed by both per protocol and intention to treat assessments.

  4 weeks

Interventions

esomeprazole 40 mg DRUG

40 mg daily for 4 weeks

Also known as: Nexium

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of GERD
• Nighttime heartburn

You may not qualify if:

• Less than 18 years old or older than 60 years of age
• Any conditions other than GERD that could be the primary cause of or a factor in your sleep disturbance. These include but are not limited to: severe anxiety, severe depression, panic attacks, sleep apnea, blocked airways, chronic pulmonary disease requiring oxygen therapy
• Restless leg syndrome
• Excessive need for nighttime urination (more than 2 times per night)
• Insomnia
• Excessive caffeine use (more than 4 standard 8-oz cups of coffee or caffeinated beverages, or 2 12-oz caffeinated sodas per day) or within 3 hours of sleep time
• Buerger's disease
• Use of a proton pump inhibitor
• Active gastrointestinal bleeding
• Severe, unresolved or unstable illnesses that the investigator feels would interfere with your participation in the study
• Severe liver disease
• Chronic illness that may cause excessive fatigue or low energy level such as chronic fatigue syndrome, or uncontrolled thyroid disease
• Need for anticoagulation therapy such as warfarin
• Active chemo or radiation therapy for cancer
• Prior gastric by-pass surgery

Sponsors & Collaborators

• David A. Johnson, MD: lead
• AstraZeneca: collaborator

Study Sites (1)

Digestive and Liver Disease Specialists

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 3, 2010
• Study Start: July 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: February 22, 2012

Record last verified: 2012-02

Locations

US (1)