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A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn
This study has been completed.
First Received: February 21, 2008   Last Updated: June 22, 2009   History of Changes
Sponsor: Takeda Global Research & Development Center, Inc.
Information provided by: Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00627016
  Purpose

The purpose of this study is to determine whether Dexlansoprazole is effective in treating patients with night heartburn.


Condition Intervention Phase
Gastroesophageal Reflux
Drug: Dexlansoprazole
Drug: placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:


Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:
  • The percentage of nights without heartburn over 4 weeks as assessed by daily diary. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects with relief of night time heartburn over the last 7 days of treatment as assessed by daily diary. Relief defined as 6 of 7 days with no night time heartburn and maximum of 1 night with mild heartburn. [ Time Frame: Last 7 days of treatment ] [ Designated as safety issue: No ]
  • Percentage of subjects with relief of GERD associated sleep disturbances over the last 7 days of treatment as assessed by daily diary. Relief defined as 6 of 7 days with no GERD associated sleep disturbances. [ Time Frame: Last 7 days of treatment ] [ Designated as safety issue: No ]

Enrollment: 305
Study Start Date: March 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Dexlansoprazole
30 mg capsule, orally, once daily for 4 weeks
2: Placebo Comparator Drug: placebo
1 capsule, orally, once daily for 4 weeks

Detailed Description:

This 4 week study will be conducted by approximately 50 investigators in the United States in patients suffering from night heartburn.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 of non-steroidal anti-inflammatory drugs (NSAIDs), including 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 CNS effects that could mask perception of symptoms (eg, SSRIs, SNRIs). 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00627016

  Show 43 Study Locations
Sponsors and Collaborators
Takeda Global Research & Development Center, Inc.
Investigators
Study Chair: Medical Director Takeda Global Research & Development Center, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Takeda Global Research & Development Center, Inc. ( Sr. VP Clinical Sciences )
Study ID Numbers: T-GD07-170
Study First Received: February 21, 2008
Last Updated: June 22, 2009
ClinicalTrials.gov Identifier: NCT00627016     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:
Non-Erosive Gastroesophageal Reflux Disease
GERD
heartburn
sleep disturbance
nocturnal Reflux

Additional relevant MeSH terms:
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions
Esophageal Motility Disorders
Deglutition Disorders
Signs and Symptoms
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Heartburn
Esophageal Diseases
Lansoprazole

ClinicalTrials.gov processed this record on November 20, 2009