Efficacy of Dexlansoprazole MR on Heartburn Control in Participants Previously Receiving Twice Daily Proton Pump Inhibitor Therapy

Last updated: February 1, 2012
Sponsor: Takeda
Overall Status: Completed

Phase

3

Condition

Gastroesophageal Reflux Disease (Gerd)

Esophageal Disorders

Heartburn (Pediatric)

Treatment

N/A

Clinical Study ID

NCT00847808
T-GD08-178
U1111-1112-1761
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine if patients with well-controlled heartburn symptoms on twice-daily proton pump inhibitor therapy remain well-controlled after stepping down to once-daily (QD) dexlansoprazole modified release (MR) 30 mg.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Prior to any study-specific procedures being performed, the participant voluntarilysigns an Investigational Review Board-approved informed consent form (ICF) and anyprivacy statement/authorization form required (eg, The Health Insurance Portabilityand Accountability Act (HIPAA) authorization)

  2. Has a history of gastroesophageal reflux disease symptom, including heartburn, priorto therapy, who are currently being treated with twice daily proton pump inhibitors,excluding Dexilant (dexlansoprazole).

  3. Taking a stable dose of any twice daily proton pump inhibitors for less than or equalto 1 year and greater than 8 weeks prior to Screening.

  4. Participant is well-controlled on their current twice daily proton pump inhibitors.

  5. Females cannot be nursing and must have a negative urine pregnancy test at Day -1 orbe of non-childbearing potential. If females are of child bearing potential, must havea negative serum human chorionic gonadotropin (hCG) pregnancy test during Screeningand on an acceptable form of contraception, or have had bilateral tubal ligation ifperformed a minimum of 90 days prior to Day 1.

Exclusion

Exclusion Criteria:

  1. Has a history of co-existing diseases affecting the esophagus, history of radiationtherapy or cryotherapy to the esophagus, caustic or physiochemical trauma such assclerotherapy to the esophagus.

  2. Has active gastric or duodenal ulcers during the 30 days prior to Screening.

  3. Has acute upper gastrointestinal hemorrhage during the 30 days prior to Screening.

  4. Has current or historical evidence of Zollinger-Ellison syndrome or otherhypersecretory condition.

  5. Has known hypersensitivity to any proton pump inhibitor or any component ofdexlansoprazole MR.

  6. Use of any Histamine type-2 receptor antagonist or antacids during Screening oranticipated use during the study treatment period.

  7. Use of the following medications 7 days prior to Screening or anticipated use duringthe study:

  • Sucralfate.

  • Misoprostol.

  • Systemic corticosteroids.

  • Prokinetics (to include metoclopramide, cisapride, tegaserod).

  • Bisphosphonates during the 6 months prior to Screening or anticipated use duringthe study.

  • Chronic use (> 12 doses per month) of nonsteroidal anti-inflammatory drugs

  • Drugs with significant anticholinergic effects such as tricyclic antidepressantsor drugs with central nervous system effects that could mask perception ofsymptoms.

  • Any investigational drug(s) within 30 days of Screening.

  1. Has received blood products within the 3 months prior to Screening.

  2. History of alcohol abuse or illegal drug use or drug addiction in the 12 months priorto Screening.

  3. Evidence of uncontrolled, clinically significant neurologic, cardiovascular,pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or otherabnormality, which may impact the ability of the participant to participate orpotentially confound the study results.

  4. Atypical manifestations of gastroesophageal reflux disease.

  5. Has abnormal screening laboratory values that suggest a clinically significantunderlying disease or condition.

  6. Cancer within 5 years prior to Screening.

  7. Is known to have acquired immunodeficiency syndrome.

  8. Has any condition that is likely to require inpatient surgery during the course of thestudy.

  9. Surgery of the acute upper gastrointestinal tract, including bariatric.

  10. Is in the opinion of the investigator unable to comply with the requirements of thestudy or are unsuitable for any reason.

Study Design

Total Participants: 178
Study Start date:
February 01, 2009
Estimated Completion Date:
April 30, 2010

Study Description

Gastroesophageal reflux disease is recognized as a common and persistent medical problem in the US adult population. Gastroesophageal reflux disease comprises a spectrum of acid-related disorders including symptomatic nonerosive gastroesophageal reflux disease and erosive esophagitis. It affects men and women in nearly equal proportions, and the severity and intensity of heartburn symptoms may be similar in both types of patients.

Dexlansoprazole modified release is a dual delayed release formulation that consists of two types of granules contained in a single capsule. This dual delayed release formulation is designed to extend the duration of drug exposure and maintain pharmacologically active levels over a longer time period.

The purpose of this study is to demonstrate that participants with gastroesophageal reflux disease whose symptoms are well-controlled on twice daily proton pump inhibitors, remain well-controlled when switched to dexlansoprazole MR.

Connect with a study center

  • Hueytown, Alabama
    United States

    Site Not Available

  • Chandler, Arizona
    United States

    Site Not Available

  • Sierra Vista, Arizona
    United States

    Site Not Available

  • Tucson, Arizona
    United States

    Site Not Available

  • Sherman, Arkansas
    United States

    Site Not Available

  • Sherwood, Arkansas
    United States

    Site Not Available

  • Carmichael, California
    United States

    Site Not Available

  • Garden Grove, California
    United States

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  • Laguna Hills, California
    United States

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  • Long Beach, California
    United States

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  • Paramount, California
    United States

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  • Rancho Cucamonga, California
    United States

    Site Not Available

  • Roseville, California
    United States

    Site Not Available

  • Sacramento, California
    United States

    Site Not Available

  • San Diego, California
    United States

    Site Not Available

  • San Ramon, California
    United States

    Site Not Available

  • Tustin, California
    United States

    Site Not Available

  • Westlake Village, California
    United States

    Site Not Available

  • Bristol, Connecticut
    United States

    Site Not Available

  • Boynton Beach, Florida
    United States

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  • Hialeah, Florida
    United States

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  • New Smyrna Beach, Florida
    United States

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  • Winter Haven, Florida
    United States

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  • Augusta, Georgia
    United States

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  • Conyers, Georgia
    United States

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  • Newman, Georgia
    United States

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  • Stockbridge, Georgia
    United States

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  • Rockford, Illinois
    United States

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  • Metairie, Louisiana
    United States

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  • Prince Frederick, Maryland
    United States

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  • Stevensville, Michigan
    United States

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  • Olive Branch, Mississippi
    United States

    Site Not Available

  • Egg Harbor Township, New Jersey
    United States

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  • Albuquerque, New Mexico
    United States

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  • Rochester, New York
    United States

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  • Wilmington, North Carolina
    United States

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  • Columbus, Ohio
    United States

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  • Oklahoma City, Oklahoma
    United States

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  • Yukon, Oklahoma
    United States

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  • Portland, Oregon
    United States

    Site Not Available

  • Lansdale, Pennsylvania
    United States

    Site Not Available

  • Salisbury, South Carolina
    United States

    Site Not Available

  • Chattanooga, Tennessee
    United States

    Site Not Available

  • Johnson City, Tennessee
    United States

    Site Not Available

  • Nashville, Tennessee
    United States

    Site Not Available

  • Dallas, Texas
    United States

    Site Not Available

  • El Paso, Texas
    United States

    Site Not Available

  • Houston, Texas
    United States

    Site Not Available

  • South Ogden, Utah
    United States

    Site Not Available

  • Chesapeake, Virginia
    United States

    Site Not Available

  • Norfolk, Virginia
    United States

    Site Not Available

  • Lakewood, Washington
    United States

    Site Not Available

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