Clinical trial NCT00627016: A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn
Official title: A Phase 3 Multicenter, Randomized, Double-Blind, Parallel Group, Placebo Controlled Trial to Evaluate the Efficacy of TAK-390MR (30 mg QD) Compared to Placebo on Relief of Nocturnal Heartburn in Subjects With Symptomatic Gastroesophageal Reflux Disease (GERD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux
Keywords: Non-Erosive Gastroesophageal Reflux Disease
GERD
heartburn
sleep disturbance
nocturnal Reflux
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2008-02-29
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Dexlansoprazole once daily (QD) is effective in treating patients with night heartburn.

Detailed description: This 4 week study of Dexlansoprazole (TAK-390MR) will be conducted by approximately 50 investigators in the United States in patients suffering from night heartburn.

Eligibility criteria: Inclusion Criteria:

* Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
* History of nocturnal heartburn and GERD associated sleep disturbances prior to screening.
* Meets both of the following criteria: 1) nocturnal heartburn severity of moderate, severe, or very severe on at least 3 of 7 nights and; 2) GERD related sleep disturbances on at least 3 of 7 nights.
* Subjects must have history of symptomatic GERD prior to screening with GERD symptoms that were responsive to acid-suppressive therapy.

Exclusion Criteria:

* Erosive esophagitis visualized during the screening endoscopy.
* Allergy to any proton pump inhibitor drug (lansoprazole, omeprazole, rabeprazole, pantoprazole, esomeprazole), any component of Dexlansoprazole, or Gelusil/antacid.
* Active gastric or duodenal ulcers within 30 days prior to randomization.
* Upper gastrointestinal bleeding within 6 months prior to randomization.
* Co-existing diseases affecting the esophagus (eg, eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, and/or Barrett's esophagus).
* History of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus.
* Subject requiring dilation for esophageal strictures and/or strictures preventing passage of the endoscope during the screening endoscopy. Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter) is acceptable.
* Has another condition that could be the primary cause of the subject's sleep disturbance.
* Evidence of uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality (other than the disease being studied) which may impact the ability of the subject to participate or potentially confound the trial results.
* Diagnosis of cancer (except basal cell carcinoma) within 5 years of screening.
* Has a condition likely to require surgery during the study.
* Currently diagnosed with acquired immunodeficiency syndrome (AIDS).
* Abnormal clinical laboratory values.
* History of alcoholism or drug addiction.
* Subject who works the night shift.
* Subject who is planning to travel beyond 3 time zones during the study.
* Chronic use (more than 12 doses/month) of non-steroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (COX 2) inhibitors within 30 days prior to randomization or anticipated use during the study.
* Use of the following medications during the 14 days prior to randomization or anticipated use during the study: proton pump inhibitors, sucralfate, misoprostol, corticosteroids, prokinetics, anticoagulant therapy, antiseizure medications (other than stable doses), psychotropic medications (other than stable doses), narcotic medications (occasional use allowed), bisphosphonates.
* Use of sleep medications, first generation antihistamines, benzodiazepines, modified cyclic antidepressants, antianxiety medications or drugs with significant anticholinergic effects such as tricyclic antidepressants or drugs with central nervous system effects that could mask perception of symptoms (eg, selective-serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors). However, subjects who remain on a stable regimen and dose of these medications during the 90 days prior to randomization and who agree to maintain the same regimen and dose during the trial will qualify. Also, short term use of anticholinergics for trial related procedures is not exclusionary. Second generation antihistamines are not excluded.
* Use of histamine (H2) receptor antagonists or antacids (except for trial supplied Gelusil) during the screening period or anticipated use during the treatment period.

Primary outcomes:
measure: Median Percentage of Nights Without Heartburn Over 4 Weeks as Assessed by Daily Diary.
timeFrame: 4 Weeks
Secondary outcomes:
measure: Percent of Subjects With Relief of Night Time Heartburn Over the Last 7 Days of Treatment as Assessed by Daily Diary.
timeFrame: Last 7 days of treatment
measure: Percentage of Participants With Relief of Gastro-Esophageal Reflux Disease (GERD) Associated Sleep Disturbances Over the Last 7 Days of Treatment as Assessed by Daily Diary.
timeFrame: Last 7 days of treatment
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Lancaster
country: United States
state: California
city: Oakland
country: United States
state: California
city: San Diego
country: United States
state: California
city: Sherwood
country: United States
state: California
city: Westlake Village
country: United States
state: California
city: Jupiter
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: New Smyrna Beach
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Zephyrhills
country: United States
state: Florida
city: Moline
country: United States
state: Illinois
city: Clive
country: United States
state: Iowa
city: Wichita
country: United States
state: Kansas
city: Metairie
country: United States
state: Louisiana
city: Prince Frederick
country: United States
state: Maryland
city: Jefferson City
country: United States
state: Missouri
city: Egg Harbor Town
country: United States
state: New Jersey
city: Great Neck
country: United States
state: New York
city: Greensboro
country: United States
state: North Carolina
city: Harrisburg
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Mogadore
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Duncansville
country: United States
state: Pennsylvania
city: Bristol
country: United States
state: Tennessee
city: Chattanooga
country: United States
state: Tennessee
city: Johnson City
country: United States
state: Tennessee
city: Kingsport
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: El Paso
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Odessa
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Ogden
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Monroe
country: United States
state: Wisconsin
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_CHAIR
References:
citation: Fass R, Johnson DA, Orr WC, Han C, Mody R, Stern KN, Pilmer BL, Perez MC. The effect of dexlansoprazole MR on nocturnal heartburn and GERD-related sleep disturbances in patients with symptomatic GERD. Am J Gastroenterol. 2011 Mar;106(3):421-31. doi: 10.1038/ajg.2010.458. Epub 2011 Jan 11.