Trial Outcomes & Findings for 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 (NCT NCT02162758)

NCT ID: NCT02162758

Last Updated: 2017-05-11

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: Month 12
• Results posted on: 2017-05-11

Participant Flow

Participants took part in the study at 2 investigative sites in the United States from 16 July 2014 to 09 May 2016.

Participants with a diagnosis of Barrett's esophagus (BE) who had achieved complete eradication of intestinal metaplasia (CEIM) with radiofrequency ablation (RFA) were enrolled in 1 of the 2 treatment groups: Dexlansoprazole 60 milligram (mg), once-daily (QD); Dexlansoprazole 60 mg, twice daily (BID).

Participant milestones

Measure	Dexlansoprazole 60 mg QD Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.	Dexlansoprazole 60 mg BID Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
Overall Study STARTED	3	3
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Dexlansoprazole 60 mg QD Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.	Dexlansoprazole 60 mg BID Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
Overall Study Study termination	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Dexlansoprazole 60 mg QD n=3 Participants Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.	Dexlansoprazole 60 mg BID n=3 Participants Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.	Total n=6 Participants Total of all reporting groups
Age, Continuous	70.3 years STANDARD_DEVIATION 8.50 • n=5 Participants	67.7 years STANDARD_DEVIATION 6.81 • n=7 Participants	69.0 years STANDARD_DEVIATION 7.04 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Race/Ethnicity, Customized White	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Height	179.3 centimeter (cm) STANDARD_DEVIATION 4.04 • n=5 Participants	167.3 centimeter (cm) STANDARD_DEVIATION 15.53 • n=7 Participants	173.3 centimeter (cm) STANDARD_DEVIATION 12.09 • n=5 Participants
Weight	96.80 kilogram (kg) STANDARD_DEVIATION 20.264 • n=5 Participants	88.83 kilogram (kg) STANDARD_DEVIATION 8.170 • n=7 Participants	92.82 kilogram (kg) STANDARD_DEVIATION 14.491 • n=5 Participants
Body Mass Index (BMI)	29.95 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 4.992 • n=5 Participants	31.93 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.212 • n=7 Participants	30.94 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 3.908 • n=5 Participants
Smoking History Never smoked	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Smoking History Ever smoked	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Number of Smoking Years for Ever Smoked 16-20 years	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Number of Smoking Years for Ever Smoked Greater than (>) 20 years	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Current Smoking Status Non smoker	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Current Smoking Status Smoker	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Number of Packs Per Year 101-200 packs	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Number of Packs Per Year 301-400 packs	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Number of Packs Per Year >400 packs	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Number of Packs Per Year Unknown	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Alcohol History Never drank alcohol	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Alcohol History Drank alcohol	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Number of Drinking Years >20 years	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Number of Drinking Years Unknown	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Number of Drinks Per Week 0-5 drinks	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Number of Drinks Per Week 6-10 drinks	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Number of Drinks Per Week >30 drinks	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Current Alcohol Status Current drinker	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants
Current Alcohol Status Non-drinker	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Month 12

Population: 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.

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

Outcome measures

Measure	Dexlansoprazole 60 mg QD n=3 Participants Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.	Dexlansoprazole 60 mg BID n=2 Participants Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
Percentage of Participants With Recurrence of Intestinal Metaplasia (IM)	0 percentage of participants	50 percentage of participants

SECONDARY outcome

Timeframe: Month 12

Population: 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.

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

Outcome measures

Measure	Dexlansoprazole 60 mg QD n=3 Participants Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.	Dexlansoprazole 60 mg BID n=2 Participants Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
Percentage of Participants With Recurrence of IM With Dysplasia	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Month 12

Population: 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.

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.

Outcome measures

Measure	Dexlansoprazole 60 mg QD n=3 Participants Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.	Dexlansoprazole 60 mg BID n=2 Participants Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
Percentage of Participants With Erosive Esophagitis (EE)	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: 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.

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).

Outcome measures

Measure	Dexlansoprazole 60 mg QD n=3 Participants Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.	Dexlansoprazole 60 mg BID n=3 Participants Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
Change From Baseline in the Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Total Score Baseline	7.3 units on scale Standard Deviation 10.21	12.0 units on scale Standard Deviation 10.00
Change From Baseline in the Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) Total Score Change at Month 12	-3.0 units on scale Standard Deviation 3.00	-11.0 units on scale Standard Deviation 8.54

Adverse Events

Dexlansoprazole 60 mg QD

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Dexlansoprazole 60 mg BID

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dexlansoprazole 60 mg QD n=3 participants at risk Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.	Dexlansoprazole 60 mg BID n=3 participants at risk Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
Vascular disorders Hypotension	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.	33.3% 1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.
Respiratory, thoracic and mediastinal disorders Aspiration pneumonia	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.	33.3% 1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.
Musculoskeletal and connective tissue disorders Worsening of back pain	33.3% 1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.

Other adverse events

Measure	Dexlansoprazole 60 mg QD n=3 participants at risk Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.	Dexlansoprazole 60 mg BID n=3 participants at risk Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
Gastrointestinal disorders Dyspepsia	66.7% 2/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.
Cardiac disorders Tachycardia	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.	33.3% 1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.
General disorders Pyrexia	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.	33.3% 1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.
Infections and infestations Pneumonia	33.3% 1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.	33.3% 1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.
Infections and infestations Sepsis	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.	33.3% 1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.	33.3% 1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.
Psychiatric disorders Mental status changes	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.	33.3% 1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.	33.3% 1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.	33.3% 1/3 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after last dose of study drug (Month 13). 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.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: trialdisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
• Publication restrictions are in place

Restriction type: OTHER