Phase 4
N=296
Dexlansoprazole in Asian Participants With Gastroesophageal Reflux Disease
Gastroesophageal Reflux Disease
Bottom Line
View on ClinicalTrials.gov: NCT02351960 ↗Enrolled (actual)
296
Serious AEs
0.7%
Results posted
Oct 2017
Primary outcome: Primary: Percentage of 24-Hour Heartburn and Acid Regurgitation-Free Days in Non-Erosive Reflux Disease (NERD) Participants — 26.92 percentage of days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexlansoprazole (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of 24-Hour Heartburn and Acid Regurgitation-Free Days in Non-Erosive Reflux Disease (NERD) Participants |
26.92 | — |
| PRIMARY Percentage of 24-Hour Heartburn and Acid Regurgitation-Free Days in Erosive Esophagitis (EE) Participants |
65.45 | — |
| SECONDARY Percentage of 24-hour Heartburn-free Days |
53.85; 81.97 | — |
| SECONDARY Percentage of 24-hour Acid Regurgitation-free Days |
75.00; 88.46 | — |
| SECONDARY Percentage of Nights (Participant Sleep Time) Without Nighttime Heartburn and Acid Regurgitation |
59.26; 83.33 | — |
| SECONDARY Percentage of Nights (Participant Sleep Time) Without Nighttime Heartburn |
73.08; 92.73 | — |
| SECONDARY Percentage of Nights (Participant Sleep Time) Without Nighttime Acid Regurgitation |
88.00; 92.59 | — |
| SECONDARY Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms |
77; 51; 92; 21; 20; 3 | — |
| SECONDARY Percentage of Participants in the EE Group Who Had Endoscopically Evaluated Macroscopic Healing of Their Esophagus |
77.3 | — |
Summary
The purpose of this study is to evaluate the effectiveness of symptom control in gastroesophageal reflux disease (GERD) participants following treatment with dexlansoprazole.
Eligibility Criteria
Inclusion Criteria: -
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements
- The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any procedures
- Has persistent typical gastroesophageal reflux disease (GERD) symptoms (heartburn and/or acid regurgitation) for at least 6 months and a frequency of GERD symptoms is at least 4 days within the past 7 days prior to the screening visit
- Meets one of the following diagnoses verified by the screening endoscopy
- Has macroscopically normal esophageal mucosa on endoscopy and may thereby be eligible for assignment to the nonerosive reflux disease (NERD) study group
- Has evidence of erosive esophageal reflux disease on endoscopy, Los Angeles (LA) classification grades B-D, and thereby may be eligible for assignment to the erosive esophagitis (EE) study group
- Is able and willing to record GERD symptoms in a subject diary and has completed the diary at least for 7 consecutive days during the screening period
- Male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study
- All female participants of childbearing potential must have a negative urine pregnancy test at Screening and a negative urine pregnancy test at Day -1. Participants who have had a bilateral tubal ligation, hysterectomy or are post-menopausal (the absence of menses for 1-2 years with a Follicle-Stimulating Hormone [FSH] level >40 IU/L or absence of menses for >2 years) are not required to use birth control
Exclusion Criteria
- Has received any investigational compound within 30 days prior to Screening
- Known hypersensitivity to any proton pump inhibitor (including lansoprazole, omeprazole, rabeprazole, pantoprazole or esomeprazole), any component of dexlansoprazole
- Use of a H2 blocker or a PPI other than dexlansoprazole during screening and throughout the study. Previous use of Dexlansoprazole before screening
- Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus
- Active gastric or duodenal ulcers within 4 weeks of the first dose of study drug
- History of dilatation of esophageal strictures, other than a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter)
- Co-existing diseases affecting the esophagus, (eg, esophageal varices, scleroderma, viral, fungal infection or esophageal stricture), history of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus
- Chronic use (>12 doses/month) of non-;steroidal anti-inflammatory drugs (NSAIDs) including COX 2 NSAIDs within 30 days prior to screening period and throughout the study, however, low dose aspirin up to 325 mg per day is allowed
- In the judgment of the investigator, participant has clinically significant abnormal hematological parameters of hemoglobin, hematocrit, or erythrocytes at Screening
- Has a history or clinical manifestations of significant organ failure which would preclude their successful completion of the study
- Participants using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose for 4 weeks prior to dosing and throughout the study
- Participants with known biliary disease
- Participants with the need for continuous anticoagulant therapy
- Participants with cancer (except basal cell and squamous cell carcinoma of the skin) within
Data sourced from ClinicalTrials.gov (NCT02351960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.