A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn

NCT ID: NCT00627016

Last Updated: 2011-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 305 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-03-31

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.

Conditions

Gastroesophageal Reflux

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dexlansoprazole 30 mg QD

Group Type: EXPERIMENTAL

Dexlansoprazole

Intervention Type: DRUG

30 mg capsule, orally, once daily for 4 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1 capsule, orally, once daily for 4 weeks

Interventions

Dexlansoprazole

30 mg capsule, orally, once daily for 4 weeks

Intervention Type: DRUG

Placebo

1 capsule, orally, once daily for 4 weeks

Intervention Type: DRUG

Other Intervention Names

TAK-390; T-168390; TAK-390MR; Kapidex; Dexilant

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Takeda Global Research & Development Center, Inc.

Principal Investigators

Medical Director

Role: STUDY_CHAIR

Takeda

Locations

Tucson, Arizona, United States

Anaheim, California, United States

Garden Grove, California, United States

Lancaster, California, United States

Oakland, California, United States

San Diego, California, United States

Sherwood, California, United States

Westlake Village, California, United States

Jupiter, Florida, United States

Miami, Florida, United States

New Smyrna Beach, Florida, United States

Ocala, Florida, United States

St. Petersburg, Florida, United States

Zephyrhills, Florida, United States

Moline, Illinois, United States

Clive, Iowa, United States

Wichita, Kansas, United States

Metairie, Louisiana, United States

Prince Frederick, Maryland, United States

Jefferson City, Missouri, United States

Egg Harbor Town, New Jersey, United States

Great Neck, New York, United States

Greensboro, North Carolina, United States

Harrisburg, North Carolina, United States

Winston-Salem, North Carolina, United States

Mogadore, Ohio, United States

Oklahoma City, Oklahoma, United States

Portland, Oregon, United States

Duncansville, Pennsylvania, United States

Bristol, Tennessee, United States

Chattanooga, Tennessee, United States

Johnson City, Tennessee, United States

Kingsport, Tennessee, United States

Nashville, Tennessee, United States

El Paso, Texas, United States

Fort Worth, Texas, United States

Houston, Texas, United States

Odessa, Texas, United States

San Antonio, Texas, United States

Ogden, Utah, United States

Norfolk, Virginia, United States

Spokane, Washington, United States

Monroe, Wisconsin, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21224838 (View on PubMed)

Related Links

http://general.takedapharm.com/content/file/pi.pdf?applicationcode=9efb34b3-fb69-4190-a2be-a90b8cb94e25&filetypecode=DEXILANTPI

Dexilant Package Insert

Other Identifiers

U1111-1113-9537

Identifier Type: REGISTRY

Identifier Source: secondary_id

T-GD07-170

Identifier Type: -

Identifier Source: org_study_id