Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn

NCT00251758 | Completed Phase 3 Results

• 2 other identifiers: T-GD04-083U1111-1114-1811
• Study Type: interventional
• Target: 908
• Locations: 1 country
• Sites: 99

Brief Summary

The purpose of this study is to assess the efficacy and safety of daily treatment with Dexlansoprazole modified release (MR) (60 mg or 90 mg once daily \[QD\]) compared to placebo QD in relief of daytime and nighttime heartburn over 4 weeks in subjects with gastroesophageal reflux disease (GERD).

Conditions

Gastroesophageal Reflux Disease

Keywords

Non-Erosive Gastroesophageal Reflux Disease(GERD),heartburn

Outcome Measures

Primary Outcomes (2)

• Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median

  The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.

  4 weeks

• Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean

  The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.

  4 weeks

Secondary Outcomes (2)

• Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median

  4 weeks

• Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean

  4 weeks

Study Arms (3)

Dexlansoprazole MR 60 mg QD

EXPERIMENTAL

Drug: Dexlansoprazole MR

Dexlansoprazole MR 90 mg QD

EXPERIMENTAL

Drug: Dexlansoprazole MR

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dexlansoprazole MR DRUG

Dexlansoprazole MR 60 mg, capsules, orally, once daily for 4 weeks.

Also known as: TAK-390MR, Kapidex, Dexilant

Dexlansoprazole MR 60 mg QD

Placebo DRUG

Dexlansoprazole placebo-matching capsules, orally, once daily for 4 weeks.

Placebo

Eligibility Criteria

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

You may qualify if:

• Subjects with Non-Erosive Gastroesophageal Reflux Disease identifying their main symptom as heartburn.
• History of episodes of heartburn for 6 months or longer prior to screening.
• History of episodes of heartburn for 4 or more days during the 7 days prior to Day -1 as recorded in the electronic diary.

You may not qualify if:

• Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study
• Erosive Esophagitis seen on endoscopy during study screening.
• Co-existing diseases affecting the esophagus.
• Abnormal laboratory values that suggest significant clinical disease.
• Known acquired immunodeficiency syndrome (AIDS)
• Females pregnant or lactating.
• History of Alcohol abuse.
• History of Cancer within 3 years prior to screening.
• Chronic (\>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors
• Use of antacids (except for study supplied Gelusil® )
• Use of drugs with significant anticholinergic effects
• Need for continuous anticoagulant (blood thinner) therapy
• Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
• History of dilatation of esophageal strictures, other than a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)
• Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition

Sponsors & Collaborators

• Takeda: lead

Study Sites (99)

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Anniston, Alabama, United States

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Hueytown, Alabama, United States

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Huntsville, Alabama, United States

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Tallassee, Alabama, United States

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Tuscaloosa, Alabama, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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North Little Rock, Arkansas, United States

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Azusa, California, United States

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Carmichael, California, United States

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Cypress, California, United States

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Fresno, California, United States

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Los Angeles, California, United States

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Modesto, California, United States

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Newport Beach, California, United States

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Oakland, California, United States

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Orange, California, United States

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San Diego, California, United States

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Santa Maria, California, United States

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Littleton, Colorado, United States

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Longmont, Colorado, United States

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Wheat Ridge, Colorado, United States

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Bristol, Connecticut, United States

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Newark, Delaware, United States

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Fort Myers, Florida, United States

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Miami, Florida, United States

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Naples, Florida, United States

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New Smyrna Beach, Florida, United States

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Ocala, Florida, United States

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Pembroke Pines, Florida, United States

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Port Orange, Florida, United States

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Sarasota, Florida, United States

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St. Petersburg, Florida, United States

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Zephyrhills, Florida, United States

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Atlanta, Georgia, United States

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Champaign, Illinois, United States

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Moline, Illinois, United States

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North Chicago, Illinois, United States

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Oak Forest, Illinois, United States

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Springfield, Illinois, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Newburgh, Indiana, United States

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Davenport, Iowa, United States

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Kansas City, Kansas, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Chevy Chase, Maryland, United States

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Prince Frederick, Maryland, United States

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Jackson, Mississippi, United States

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Jefferson City, Missouri, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Missoula, Montana, United States

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Egg Harbor, New Jersey, United States

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Albuquerque, New Mexico, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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High Point, North Carolina, United States

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Raleigh, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Bismarck, North Dakota, United States

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Akron, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Mogadore, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Anderson, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Sioux Falls, South Dakota, United States

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Chattanooga, Tennessee, United States

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Germantown, Tennessee, United States

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Jackson, Tennessee, United States

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Johnson City, Tennessee, United States

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Kingsport, Tennessee, United States

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Amarillo, Texas, United States

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Conroe, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Odessa, Texas, United States

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Pharr, Texas, United States

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Seguin, Texas, United States

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Temple, Texas, United States

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Salt Lake City, Utah, United States

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Charlottesville, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Bellevue, Washington, United States

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Lakewood, Washington, United States

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Tacoma, Washington, United States

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Milwaukee, Wisconsin, United States

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Related Links

• For the Dexilant Package Insert refer to this link

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Dexlansoprazole; Lansoprazole

Condition Hierarchy (Ancestors)

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

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

Results Point of Contact

• Title: Sr. VP Clinical Sciences
• Organization: Takeda Global Research & Development Center, Inc.

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Expanded Access: Yes

Study Record Dates

• First Submitted: November 8, 2005
• First Posted: November 10, 2005
• Study Start: December 1, 2005
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: May 18, 2010
• Results First Posted: March 23, 2009

Record last verified: 2010-05

Locations

US (99)