Effect of Pantoprazole 40mg Daily vs Placebo on Power Spectral Analysis of the Sleep EEG of Patients With GERD.

NCT00674245 | Completed Phase 2

• 1 other identifier: 08-0001-01 & R&D#00-77
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine if treatment with pantoprazole 40 mg daily versus a placebo improves sleep quality in patients with gastroesophageal reflux disease (GERD). Another purpose is to determine if treatment with pantoprazole 40 mg once daily versus a placebo improves sleep outcomes in patients with gastroesophageal reflux disease using spectral analysis of sleep electroencephalogram (EEG).

Conditions

Gastroesophageal Reflux Disease

Keywords

heartburn; acid reflux; GERD; spectrum analysis; electroencephalogram; esophagitis; peptic

Outcome Measures

Primary Outcomes (1)

• Symptom control after 4 weeks of treatment.

  To determine if treatment with pantoprazole 40 mg daily vs placebo improves sleep quality in patients with GERD.

  April 2008 to July 2010

Secondary Outcomes (1)

• Effect of Pantoprazole 40 mg Daily vs Placebo on the Power Spectral Analysis of the Sleep Electroencephalogram of Patients With GERD.

  April 2008-July 2010

Study Arms (2)

Pantoprazole

ACTIVE COMPARATOR

40 mg once daily for four weeks improves sleep quality in patients with GERD

Drug: Pantoprazole

placebo

PLACEBO COMPARATOR

To determine if treatment with pantoprazole 40 mg once daily vs placebo improves sleep outcome in patients with GERD.

Drug: placebo

Interventions

Pantoprazole DRUG

40 mg once daily for 4 weeks

Also known as: Protonix, PPI

Pantoprazole

placebo DRUG

40 mg once daily for 4 weeks

Also known as: sugar pill

placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 yrs of age
• to 3 episodes of GERD/week
• erosive esophagitis or abnormal 24 hr pH
• able to read and understand, complete questionnaires

You may not qualify if:

• barrett's esophagus or peptic stricture on endoscopy
• normal EGD and normal 24 hour pH
• previous upper GI surgery
• comorbidity (cardiovascular, respiratory, renal, hepatic)
• use of narcotics or pain medication on regular basis
• insomnia, shift work sleep disorder, sleep apnea, restless leg syndrome
• diabetes, scleroderma or neuromuscular disorders

Sponsors & Collaborators

• Southern Arizona VA Health Care System: lead

Study Sites (1)

Southern Arizona VA Health Care System

Tucson, Arizona, 85723, United States

Location

Related Publications (6)

• Fass R, Fullerton S, Tung S, Mayer EA. Sleep disturbances in clinic patients with functional bowel disorders. Am J Gastroenterol. 2000 May;95(5):1195-2000. doi: 10.1111/j.1572-0241.2000.02009.x.

  PMID: 10811327 BACKGROUND

• Wiklund IK, Junghard O, Grace E, Talley NJ, Kamm M, Veldhuyzen van Zanten S, Pare P, Chiba N, Leddin DS, Bigard MA, Colin R, Schoenfeld P. Quality of Life in Reflux and Dyspepsia patients. Psychometric documentation of a new disease-specific questionnaire (QOLRAD). Eur J Surg Suppl. 1998;(583):41-9.

  PMID: 10027672 BACKGROUND

• Orr WC, Goodrich S, Robert J. The effect of acid suppression on sleep patterns and sleep-related gastro-oesophageal reflux. Aliment Pharmacol Ther. 2005 Jan 15;21(2):103-8. doi: 10.1111/j.1365-2036.2005.02310.x.

  PMID: 15679759 BACKGROUND

• Locke GR 3rd, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ 3rd. Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology. 1997 May;112(5):1448-56. doi: 10.1016/s0016-5085(97)70025-8.

  PMID: 9136821 BACKGROUND

• Netzer NC, Stoohs RA, Netzer CM, Clark K, Strohl KP. Using the Berlin Questionnaire to identify patients at risk for the sleep apnea syndrome. Ann Intern Med. 1999 Oct 5;131(7):485-91. doi: 10.7326/0003-4819-131-7-199910050-00002.

  PMID: 10507956 BACKGROUND

• Goldsmith G, Levin JS. Effect of sleep quality on symptoms of irritable bowel syndrome. Dig Dis Sci. 1993 Oct;38(10):1809-14. doi: 10.1007/BF01296103.

  PMID: 8404401 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn; Esophagitis

Interventions

Pantoprazole; Sugars

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; Gastroenteritis

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ronnie Fass, MD

  Southern VA Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: May 5, 2008
• First Posted: May 7, 2008
• Study Start: April 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 19, 2010

Record last verified: 2010-08

Locations

US (1)