Efficacy of Dexlansoprazole MR on Heartburn Control in Participants Previously Receiving Twice Daily Proton Pump Inhibitor Therapy
NCT ID: NCT00847808
Last Updated: 2012-02-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
178 participants
INTERVENTIONAL
2009-02-28
2010-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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1
Dexlansoprazole MR QD
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
Interventions
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Dexlansoprazole MR QD
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Has a history of gastroesophageal reflux disease symptom, including heartburn, prior to 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 equal to 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 or be of non-childbearing potential. If females are of child bearing potential, must have a negative serum human chorionic gonadotropin (hCG) pregnancy test during Screening and on an acceptable form of contraception, or have had bilateral tubal ligation if performed a minimum of 90 days prior to Day 1.
Exclusion Criteria
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 other hypersecretory condition.
5. Has known hypersensitivity to any proton pump inhibitor or any component of dexlansoprazole MR.
6. Use of any Histamine type-2 receptor antagonist or antacids during Screening or anticipated use during the study treatment period.
7. Use of the following medications 7 days prior to Screening or anticipated use during the study:
* Sucralfate.
* Misoprostol.
* Systemic corticosteroids.
* Prokinetics (to include metoclopramide, cisapride, tegaserod).
* Bisphosphonates during the 6 months prior to Screening or anticipated use during the study.
* Chronic use (\> 12 doses per month) of nonsteroidal anti-inflammatory drugs
* Drugs with significant anticholinergic effects such as tricyclic antidepressants or drugs with central nervous system effects that could mask perception of symptoms.
* Any investigational drug(s) within 30 days of Screening.
8. Has received blood products within the 3 months prior to Screening.
9. History of alcohol abuse or illegal drug use or drug addiction in the 12 months prior to Screening.
10. Evidence of uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
11. Atypical manifestations of gastroesophageal reflux disease.
12. Has abnormal screening laboratory values that suggest a clinically significant underlying disease or condition.
13. Cancer within 5 years prior to Screening.
14. Is known to have acquired immunodeficiency syndrome.
15. Has any condition that is likely to require inpatient surgery during the course of the study.
16. Surgery of the acute upper gastrointestinal tract, including bariatric.
17. Is in the opinion of the investigator unable to comply with the requirements of the study or are unsuitable for any reason.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director Clinical Science
Role: STUDY_DIRECTOR
Takeda
Locations
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Hueytown, Alabama, United States
Chandler, Arizona, United States
Sierra Vista, Arizona, United States
Tucson, Arizona, United States
Sherman, Arkansas, United States
Sherwood, Arkansas, United States
Carmichael, California, United States
Garden Grove, California, United States
Laguna Hills, California, United States
Long Beach, California, United States
Paramount, California, United States
Rancho Cucamonga, California, United States
Roseville, California, United States
Sacramento, California, United States
San Diego, California, United States
San Ramon, California, United States
Tustin, California, United States
Westlake Village, California, United States
Bristol, Connecticut, United States
Boynton Beach, Florida, United States
Hialeah, Florida, United States
New Smyrna Beach, Florida, United States
Winter Haven, Florida, United States
Augusta, Georgia, United States
Conyers, Georgia, United States
Newnan, Georgia, United States
Stockbridge, Georgia, United States
Rockford, Illinois, United States
Metairie, Louisiana, United States
Prince Frederick, Maryland, United States
Stevensville, Michigan, United States
Olive Branch, Mississippi, United States
Egg Harbor, New Jersey, United States
Albuquerque, New Mexico, United States
Rochester, New York, United States
Wilmington, North Carolina, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Yukon, Oklahoma, United States
Portland, Oregon, United States
Lansdale, Pennsylvania, United States
Salisbury, South Carolina, United States
Chattanooga, Tennessee, United States
Johnson City, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
South Ogden, Utah, United States
Chesapeake, Virginia, United States
Norfolk, Virginia, United States
Lakewood, Washington, United States
Countries
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References
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Fass R, Inadomi J, Han C, Mody R, O'Neil J, Perez MC. Maintenance of heartburn relief after step-down from twice-daily proton pump inhibitor to once-daily dexlansoprazole modified release. Clin Gastroenterol Hepatol. 2012 Mar;10(3):247-53. doi: 10.1016/j.cgh.2011.11.021. Epub 2011 Dec 7.
Related Links
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Other Identifiers
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U1111-1112-1761
Identifier Type: REGISTRY
Identifier Source: secondary_id
T-GD08-178
Identifier Type: -
Identifier Source: org_study_id
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