A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn
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| ClinicalTrials.gov Identifier: NCT00627016 |
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Recruitment Status :
Completed
First Posted : February 29, 2008
Results First Posted : May 6, 2010
Last Update Posted : April 28, 2011
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Sponsor:
Takeda
Information provided by:
Takeda
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Brief Summary:
The purpose of this study is to determine whether Dexlansoprazole once daily (QD) is effective in treating patients with night heartburn.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastroesophageal Reflux | Drug: Dexlansoprazole Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 305 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| 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) |
| Study Start Date : | March 2008 |
| Actual Primary Completion Date : | March 2009 |
| Actual Study Completion Date : | March 2009 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: Dexlansoprazole 30 mg QD |
Drug: Dexlansoprazole
30 mg capsule, orally, once daily for 4 weeks
Other Names:
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| Placebo Comparator: Placebo |
Drug: Placebo
1 capsule, orally, once daily for 4 weeks |
Primary Outcome Measures :
- Median Percentage of Nights Without Heartburn Over 4 Weeks as Assessed by Daily Diary. [ Time Frame: 4 Weeks ]Percentage calculated by the number of heartburn-free nights out of the total number of nights during the treatment period with a diary entry indicating presence or absence of nighttime heartburn in subjects who had ≥1 diary entry indicating presence or absence of nighttime heartburn, as indicated by the subject's daily diary. Subjects indicate the presence (Yes/No) of nocturnal heartburn symptoms in a Daily Electronic Diary. Nights missing diary results were excluded from the numerator and denominator.
Secondary Outcome Measures :
- Percent of Subjects With Relief of Night Time Heartburn Over the Last 7 Days of Treatment as Assessed by Daily Diary. [ Time Frame: Last 7 days of treatment ]Relief of nighttime heartburn was defined as 6 of 7 nights with no heartburn and at most 1 night with mild heartburn; lack of relief of nighttime heartburn was defined as 2 or more out of 7 nights with heartburn, or 1 night with at least moderate heartburn. Subjects indicate the presence and severity (mild, moderate, severe, or very severe) of nocturnal heartburn in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of nighttime heartburn divided by the number of subjects whose relief status could be determined.
- Percentage of Participants With Relief of Gastro-Esophageal Reflux Disease (GERD) Associated Sleep Disturbances Over the Last 7 Days of Treatment as Assessed by Daily Diary. [ Time Frame: Last 7 days of treatment ]Relief of GERD-associated sleep disturbance was defined as 6 of 7 nights with no GERD associated sleep disturbances; lack of relief of GERD-associated sleep disturbance was defined as 2 or more out of 7 nights with GERD-associated sleep disturbance. Subjects indicate the presence (Yes/No) of GERD associated sleep disturbance in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of GERD-associated sleep disturbance divided by the number of subjects whose relief status could be determined.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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 (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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00627016
Locations
| United States, Arizona | |
| Tucson, Arizona, United States | |
| United States, California | |
| 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 | |
| United States, Florida | |
| Jupiter, Florida, United States | |
| Miami, Florida, United States | |
| New Smyrna Beach, Florida, United States | |
| Ocala, Florida, United States | |
| Saint Petersburg, Florida, United States | |
| Zephyrhills, Florida, United States | |
| United States, Illinois | |
| Moline, Illinois, United States | |
| United States, Iowa | |
| Clive, Iowa, United States | |
| United States, Kansas | |
| Wichita, Kansas, United States | |
| United States, Louisiana | |
| Metairie, Louisiana, United States | |
| United States, Maryland | |
| Prince Frederick, Maryland, United States | |
| United States, Missouri | |
| Jefferson City, Missouri, United States | |
| United States, New Jersey | |
| Egg Harbor Town, New Jersey, United States | |
| United States, New York | |
| Great Neck, New York, United States | |
| United States, North Carolina | |
| Greensboro, North Carolina, United States | |
| Harrisburg, North Carolina, United States | |
| Winston-Salem, North Carolina, United States | |
| United States, Ohio | |
| Mogadore, Ohio, United States | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States | |
| United States, Oregon | |
| Portland, Oregon, United States | |
| United States, Pennsylvania | |
| Duncansville, Pennsylvania, United States | |
| United States, Tennessee | |
| Bristol, Tennessee, United States | |
| Chattanooga, Tennessee, United States | |
| Johnson City, Tennessee, United States | |
| Kingsport, Tennessee, United States | |
| Nashville, Tennessee, United States | |
| United States, Texas | |
| El Paso, Texas, United States | |
| Fort Worth, Texas, United States | |
| Houston, Texas, United States | |
| Odessa, Texas, United States | |
| San Antonio, Texas, United States | |
| United States, Utah | |
| Ogden, Utah, United States | |
| United States, Virginia | |
| Norfolk, Virginia, United States | |
| United States, Washington | |
| Spokane, Washington, United States | |
| United States, Wisconsin | |
| Monroe, Wisconsin, United States | |
Sponsors and Collaborators
Takeda
Investigators
| Study Chair: | Medical Director | Takeda |
Additional Information:
Publications of Results:
Publications of Results:
| Responsible Party: | Sr. VP Clinical Sciences, Takeda Global Research & Development Center, Inc. |
| ClinicalTrials.gov Identifier: | NCT00627016 |
| Other Study ID Numbers: |
T-GD07-170 U1111-1113-9537 ( Registry Identifier: WHO ) |
| First Posted: | February 29, 2008 Key Record Dates |
| Results First Posted: | May 6, 2010 |
| Last Update Posted: | April 28, 2011 |
| Last Verified: | April 2011 |
Keywords provided by Takeda:
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Non-Erosive Gastroesophageal Reflux Disease GERD heartburn sleep disturbance nocturnal Reflux |
Additional relevant MeSH terms:
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Gastroesophageal Reflux Esophagitis, Peptic Heartburn Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Esophagitis Gastroenteritis Peptic Ulcer |
Duodenal Diseases Intestinal Diseases Stomach Diseases Signs and Symptoms, Digestive Dexlansoprazole Lansoprazole Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |