A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd and 40 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD)

NCT00628342 | Completed Phase 4

• 1 other identifier: D961AC00001
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study includes patients with sleep disturbances associated with gastroesophageal reflux disease (GERD) and has 3 treatment arms. Patients will receive only one of the following treatment arms: esomeprazole 20 mg once daily, esomeprazole 40 mg once daily, matching placebo once daily. The relief to the sleep disturbances will be assessed.

Conditions

Gastroesophageal Reflux Disease (GERD)

Keywords

Gastroesophageal Reflux Disease; GERD; Esomeprazole; Heartburn; Nexium

Outcome Measures

Primary Outcomes (1)

• Daily patient diary cards to demonstrate whether there is a difference in the relief of nighttime heartburn between esomeprazole 20 mg once daily (E20), and placebo once daily and between esomeprazole 40 mg once daily (E40) in patients with GERD.

  Daily diary cards completed by the patients.

Secondary Outcomes (3)

• To assess the impact of treatment with E20 versus placebo and E40 versus placebo on sleep disturbances associated with GERD as measured by:Change in global PSQI score; Complete resolution of sleep disturbances; Relief of sleep disturbances; Perc

  Daily diary cards completed by the patients

• To assess the impact of treatment with E20 versus placebo and E40 versus placebo on heartburn as measured by:Complete resolution of daytime heartburn; Complete resolution of nightime heartburn; Relief of daytime heartburn; Improvement in the fre

  Daily diary cards completed by the patients.

• To quantify the difference during 4 weeks of treatment between E20 and E40 in patients with GERD as measured by: - Relief of nightime heartburn - Relief of sleep disturbances associated with GERD

  Daily diary cards completed by the patients.

Study Arms (3)

1

EXPERIMENTAL

Drug: Esomeprazole

2

EXPERIMENTAL

Drug: Esomeprazole

3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Esomeprazole DRUG

20mg Oral tablet once daily

Also known as: Nexium

1

Placebo DRUG

Oral once daily

3

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A history of heartburn or acid regurgitation for 3 months or longer or any history of erosive esophagitis.
• Nightime heartburn averaging at least 2 or 3 times per week and a history of sleep disturbances associated with GERD for 1 month or more.
• Nightime heartburn graded as moderate or severe on 3 of the last 7 days of the run-in period and sleep disturbances associated with GERD as documented in the run-in diary card on at least 3 of the last 7 days of the run-in period..

You may not qualify if:

• Any condition other than GERD that is either the primary cause of, or a significant contributor to the patients sleep disturbance.
• Shift workers who work between 12am (midnight) and 6am.
• Sleep medication, antihistamine, benzodiazepine, or anti-anxiety medication use that has not been stable for at least 3 months or is not expected to remain stable during the patients participation in the study.
• Other diseases / conditions as listed in the protocol.

Sponsors & Collaborators

• AstraZeneca: lead

Related Publications (1)

• Johnson DA, Le Moigne A, Hugo V, Nagy P. Rapid resolution of sleep disturbances related to frequent reflux: effect of esomeprazole 20 mg in two randomized, double-blind, controlled trials. Curr Med Res Opin. 2015 Feb;31(2):243-50. doi: 10.1185/03007995.2014.991818. Epub 2015 Jan 9.

  PMID: 25478944 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

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

Study Officials

• Paula Fernstrom

  Nexium Global Product Director, AstraZeneca

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 26, 2008
• First Posted: March 5, 2008
• Study Start: April 1, 2003
• Primary Completion: August 1, 2003
• Study Completion: August 1, 2003
• Last Updated: March 12, 2009

Record last verified: 2009-03