Effect of Dexlansoprazole 60 mg QD and 60 mg BID on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of Barrett's Esophagus With Radiofrequency Ablation
|Barrett's Esophagus||Drug: Dexlansoprazole Drug: Dexlansoprazole Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Phase 4 Study to Evaluate the Effect of Dexlansoprazole 60 mg QD and 60 mg BID on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of Barrett's Esophagus With Radiofrequency Ablation|
- Percentage of Participants With Recurrence of Intestinal Metaplasia (IM) [ Time Frame: Month 12 ]Recurrence of IM was defined as an esophageal biopsy result indicating BE with or without dysplasia.
- Percentage of Participants With Recurrence of IM With Dysplasia [ Time Frame: Month 12 ]Recurrence of IM with dysplasia was defined as an esophageal biopsy result indicating BE with dysplasia.
- Percentage of Participants With Erosive Esophagitis (EE) [ Time Frame: Baseline up to Month 12 ]The severity of EE was classified into following grades: Grade A: one or more mucosal breaks no longer than 5 millimeter (mm), none of which extends between the tops of the mucosal folds; Grade B: one or more mucosal breaks more than 5 mm long, none of which extends between the tops of two mucosal folds; Grade C: mucosal breaks that extend between the tops of two or more mucosal folds, but which involve less than 75 percent (%) of the esophageal circumference; Grade D: mucosal breaks which involve at least 75% of the esophageal circumference.
- Change From Baseline in the Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Total Score [ Time Frame: Baseline and Month 12 ]The GERD-HRQL score consisted of 10 questions, where participants were required to answer each question on a scale of 0 to 5 (0: no symptoms; 1: symptoms noticeable but not bothersome; 2: symptoms noticeable and bothersome but not every day; 3: symptoms bothersome every day; 4: symptoms affect daily activity; 5: symptoms are incapacitating to do daily activities). The total score was derived by simply adding the individual score of each question. The total score ranged from 0 to 50 where a higher score indicated more severe disease. The best possible total GERD-HRQL score was 0 (asymptomatic in all questions) and the worst possible score is 50 (incapacitated in all questions).
|Study Start Date:||July 2014|
|Study Completion Date:||April 2016|
|Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Experimental: Dexlansoprazole 60 milligram (mg) QD
Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole 60 mg placebo-matching capsules, orally, once daily for up to 12 months.
Dexlansoprazole delayed-release capsules
Other Name: DexilantDrug: Dexlansoprazole Placebo
Dexlansoprazole placebo-matching capsules
Experimental: Dexlansoprazole 60 mg BID
Dexlansoprazole 60 mg, delayed-release capsules, orally, BID for up to 12 months.
Dexlansoprazole delayed-release capsules
Other Name: Dexilant
The drug being tested in this study is called dexlansoprazole. The purpose of this study is to evaluate the effect of 12 months of treatment with dexlansoprazole 60 mg QD or dexlansoprazole 60 mg BID on the recurrence of IM in participants who have achieved complete eradication of intestinal metaplasia (CEIM) and dysplasia (CED) with RFA. The study will enroll approximately 150 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- Dexlansoprazole 60 mg once a day and placebo (this is a capsule that looks like the study drug but has no active ingredient) once a day
- Dexlansoprazole 60 mg twice a day.
All participants will be asked to take one capsule twice a day at the same time each day throughout the study.
This randomized, double-blind, multi-center, parallel group trial will be conducted in North America. The overall time to participate in this study is up to 13 months. Participants will make 5 visits to the clinic, and will undergo a safety follow-up assessment 30 days after the last dose of study drug.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02162758
|United States, Florida|
|Jacksonville, Florida, United States, 32216|
|Jacksonville, Florida, United States|
|United States, North Carolina|
|Chapel Hill, North Carolina, United States, 27599|
|Chapel Hill, North Carolina, United States|
|United States, Tennessee|
|Knoxville, Tennessee, United States, 37909|
|Knoxville, Tennessee, United States|
|Study Director:||Medical Director Clinical Science||Takeda|