Gastroesophageal RefluxPhase 3NCT00627016
A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn
A Phase 3 study testing Dexlansoprazole in people with Gastroesophageal Reflux, run by Takeda at 43 sites in United States.
Trial summary
The purpose of this study is to determine whether Dexlansoprazole once daily (QD) is effective in treating patients with night heartburn. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Dexlansoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 305 participants
- Where
- 43 sitesUnited States
- Study dates
- Mar 2008to Mar 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Study site
Anaheim, California
Study site
Bristol, Tennessee
Study site
Chattanooga, Tennessee
Study site
Clive, Iowa
Study site
Duncansville, Pennsylvania
Study site
Egg Harbor Town, New Jersey
Study site
El Paso, Texas
Study site
Fort Worth, Texas
Study site
Garden Grove, California
Study site
Great Neck, New York
Study site
Greensboro, North Carolina
Study site
Harrisburg, North Carolina
Study site
Houston, Texas
Study site
Jefferson City, Missouri
Study site
Johnson City, Tennessee
Study site
Jupiter, Florida
Study site
Kingsport, Tennessee
Study site
Lancaster, California
Study site
Metairie, Louisiana
Study site
Miami, Florida
Study site
Mogadore, Ohio
Study site
Moline, Illinois
Study site
Monroe, Wisconsin
Study site
Nashville, Tennessee
Study site
New Smyrna Beach, Florida
Study site
Norfolk, Virginia
Study site
Oakland, California
Study site
Ocala, Florida
Study site
Odessa, Texas
Study site
Ogden, Utah
Study site
Oklahoma City, Oklahoma
Study site
Portland, Oregon
Study site
Prince Frederick, Maryland
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Sherwood, California
Study site
Spokane, Washington
Study site
St. Petersburg, Florida
Study site
Tucson, Arizona
Study site
Westlake Village, California
Study site
Wichita, Kansas
Study site
Winston-Salem, North Carolina
Study site
Zephyrhills, Florida
About this 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)
The purpose of this study is to determine whether Dexlansoprazole once daily (QD) is effective in treating patients with night heartburn.
Read the detailed description
This 4 week study of Dexlansoprazole (TAK-390MR) will be conducted by approximately 50 investigators in the United States in patients suffering from night heartburn.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Dexlansoprazole, Placebo
- Keywords
- Non-Erosive Gastroesophageal Reflux Disease, GERD, heartburn, sleep disturbance, nocturnal Reflux
- Medical subject headings
- Gastroesophageal Reflux, Heartburn, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexlansoprazoleDrug
Also called TAK-390, T-168390, TAK-390MR, Kapidex
30 mg capsule, orally, once daily for 4 weeks
PlaceboDrug
1 capsule, orally, once daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dexlansoprazole 30 mg QD | Experimental | Not described Receives: Drug: Dexlansoprazole |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Percentage of Nights Without Heartburn Over 4 Weeks as Assessed by Daily Diary.
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.
Measured: 4 Weeks
Secondary outcomes (2)
Percent of Subjects With Relief of Night Time Heartburn Over the Last 7 Days of Treatment as Assessed by Daily Diary.
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.
Measured: Last 7 days of treatment
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.
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.
Measured: Last 7 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director, Study chair, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627016
- Sponsor's protocol ID
- T-GD07-170
- Other IDs
- U1111-1113-9537
- Status last verified
- Apr 2011
- First submitted
- 21 Feb 2008
- Last updated
- 28 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Fass R, Johnson DA, Orr WC, Han C, Mody R, Stern KN, Pilmer BL, Perez MC. The effect of dexlansoprazole MR on nocturnal heartburn and GERD-related sleep disturbances in patients with symptomatic GERD. Am J Gastroenterol. 2011 Mar;106(3):421-31. doi: 10.1038/ajg.2010.458. Epub 2011 Jan 11.
PubMed 21224838
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00627016
- Acronym / sponsor ID
- T-GD07-170
- Conditions
- Gastroesophageal Reflux
- Keywords
- Non-Erosive Gastroesophageal Reflux Disease, GERD, heartburn, sleep disturbance, nocturnal Reflux
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Posted 6 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Dexlansoprazole once daily (QD) is effective in treating patients with night heartburn.
Detailed description
This 4 week study of Dexlansoprazole (TAK-390MR) will be conducted by approximately 50 investigators in the United States in patients suffering from night heartburn.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexlansoprazole 30 mg QD | Experimental | Drug: Dexlansoprazole |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexlansoprazoleAlso: TAK-390, T-168390, TAK-390MR, Kapidex30 mg capsule, orally, once daily for 4 weeks | Drug | Dexlansoprazole 30 mg QD |
| Placebo1 capsule, orally, once daily for 4 weeks | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21224838Fass R, Johnson DA, Orr WC, Han C, Mody R, Stern KN, Pilmer BL, Perez MC. The effect of dexlansoprazole MR on nocturnal heartburn and GERD-related sleep disturbances in patients with symptomatic GERD. Am J Gastroenterol. 2011 Mar;106(3):421-31. doi: 10.1038/ajg.2010.458. Epub 2011 Jan 11.
- Dexilant Package InsertLink provided by the sponsor.
Related trials for Gastroesophageal Reflux
RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study chair
Takeda
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexlansoprazole in people with Gastroesophageal Reflux, run by Takeda at 43 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Percentage of Nights Without Heartburn Over 4 Weeks as Assessed by Daily Diary. (time frame: 4 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00627016, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2011.