Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Recurrence

Barrett Esophagus

Metaplasia

Disease Attributes

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Lansoprazole

Dexlansoprazole

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

Enzyme Inhibitors

Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole 60 mg placebo-matching capsules, orally, once daily for up to 12 months.

Dexlansoprazole 60 mg, delayed-release capsules, orally, BID for up to 12 months.

Dexlansoprazole placebo-matching capsules

Dexlansoprazole Placebo

Medical Director Clinical Science

This study is designed to evaluate the effect of dexlansoprazole once daily (QD) and twice daily (BID) dosing on the recurrence of intestinal metaplasia (IM) in participants who achieved complete eradication of Barrett's esophagus (BE) with high-grade dysplasia (HGD) following radiofrequency ablation (RFA).

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.

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

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

Recurrence of IM was defined as an esophageal biopsy result indicating BE with or without dysplasia.

Recurrence of IM with dysplasia was defined as an esophageal biopsy result indicating BE with dysplasia.

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.

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).

Takeda

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.

Dexlansoprazole 60 mg QD

Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.

Dexlansoprazole 60 mg BID

Total

Age, Continuous

Sex: Female, Male

Not Hispanic or Latino

Race/Ethnicity, Customized

White

United States

Region of Enrollment

Height

Weight

Body Mass Index (BMI)

Never smoked

Ever smoked

Smoking History

16-20 years

Greater than (>) 20 years

Baseline measure was analyzed for those participants who have ever smoked tobacco.

Number of Smoking Years for Ever Smoked

Non smoker

Smoker

Current Smoking Status

101-200 packs

301-400 packs

>400 packs

Unknown

Baseline measure was analyzed in the participants who currently or have ever smoked tobacco.

Number of Packs Per Year

Never drank alcohol

Drank alcohol

Alcohol History

>20 years

Baseline measure was analyzed for those participants who currently or have ever drank alcohol.

Number of Drinking Years

0-5 drinks

6-10 drinks

>30 drinks

Number of Drinks Per Week

Current drinker

Non-drinker

Current Alcohol Status

The safety set included all participants who were randomized and received 1 dose of study drug.

Medical Director

The Intent-to-treat (ITT) population where Month 12 esophageal biopsy assessment was available. The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.

Percentage of Participants With Recurrence of Intestinal Metaplasia (IM)

The ITT population where Month 12 esophageal biopsy assessment was available. The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.

Percentage of Participants With Recurrence of IM With Dysplasia

The ITT population where EE assessment was available. The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.

Percentage of Participants With Erosive Esophagitis (EE)

Baseline

Change at Month 12

The ITT population included all randomized participants who had documented CEIM at screening and took at least 1 dose of study drug during the treatment period.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT02162758	Barrett's Esoph...	Dexlansoprazole Dexlansoprazole...	18 Years - 80 Years	Takeda
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	NCT02162758	Barrett's Esoph...	Dexlansoprazole Dexlansoprazole...	18 Years - 80 Years	Takeda

Spots Global Cancer Trial Database for dexlansoprazole placebo