Trial Outcomes & Findings for Dexlansoprazole in Asian Participants With Gastroesophageal Reflux Disease (NCT NCT02351960)

NCT ID: NCT02351960

Last Updated: 2017-10-04

Results Overview

NERD participants were asked to keep a paper diary of daily heartburn and acid regurgitation-free days and the percentage of heartburn and acid regurgitation-free days was recorded.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 296 participants
• Primary outcome timeframe: Up to Week 4
• Results posted on: 2017-10-04

Participant Flow

Participants took part in the study at 12 investigative sites in Hong Kong, South Korea, Taiwan from 19 March 2015 to 13 July 2016.

Participants with a diagnosis of non-erosive reflux disease (NERD) were enrolled to receive dexlansoprazole 30 mg and participants with erosive esophagitis (EE) were enrolled to receive dexlansoprazole 60 mg.

Participant milestones

Measure	Dexlansoprazole 30 mg Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).	Dexlansoprazole 60 mg Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
Overall Study STARTED	208	88
Overall Study COMPLETED	197	76
Overall Study NOT COMPLETED	11	12

Reasons for withdrawal

Measure	Dexlansoprazole 30 mg Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).	Dexlansoprazole 60 mg Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
Overall Study Pretreatment Event/Adverse Event	6	3
Overall Study Voluntary Withdrawal	5	4
Overall Study Significant Protocol Deviation	0	5

Baseline Characteristics

Dexlansoprazole in Asian Participants With Gastroesophageal Reflux Disease

Baseline characteristics by cohort

Measure	Dexlansoprazole 30 mg n=208 Participants Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).	Dexlansoprazole 60 mg n=88 Participants Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).	Total n=296 Participants Total of all reporting groups
Age, Continuous	53.6 years STANDARD_DEVIATION 13.62 • n=5 Participants	51.7 years STANDARD_DEVIATION 12.51 • n=7 Participants	52.6 years STANDARD_DEVIATION 13.06 • n=5 Participants
Age, Customized <45 years	60 participants n=5 Participants	29 participants n=7 Participants	89 participants n=5 Participants
Age, Customized 45-<65 years	102 participants n=5 Participants	42 participants n=7 Participants	144 participants n=5 Participants
Age, Customized ≥65 years	46 participants n=5 Participants	17 participants n=7 Participants	63 participants n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants	49 Participants n=7 Participants	121 Participants n=5 Participants
Sex: Female, Male Male	136 Participants n=5 Participants	39 Participants n=7 Participants	175 Participants n=5 Participants
Race/Ethnicity, Customized Asian	208 participants n=5 Participants	87 participants n=7 Participants	295 participants n=5 Participants
Race/Ethnicity, Customized Multiracial	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Hong Kong	13 participants n=5 Participants	6 participants n=7 Participants	19 participants n=5 Participants
Region of Enrollment Korea, Republic Of	195 participants n=5 Participants	12 participants n=7 Participants	207 participants n=5 Participants
Region of Enrollment Taiwan, Province Of China	0 participants n=5 Participants	70 participants n=7 Participants	70 participants n=5 Participants
Weight	60.26 kg STANDARD_DEVIATION 11.619 • n=5 Participants	68.84 kg STANDARD_DEVIATION 14.986 • n=7 Participants	64.55 kg STANDARD_DEVIATION 13.302 • n=5 Participants
Height	161.5 cm STANDARD_DEVIATION 8.43 • n=5 Participants	165.0 cm STANDARD_DEVIATION 9.65 • n=7 Participants	163.25 cm STANDARD_DEVIATION 9.04 • n=5 Participants
Body Mass Index	23.00 kg/m^2 STANDARD_DEVIATION 3.305 • n=5 Participants	25.11 kg/m^2 STANDARD_DEVIATION 4.160 • n=7 Participants	24.05 kg/m^2 STANDARD_DEVIATION 3.732 • n=5 Participants
BMI categories <25 kg/m^2	158 participants n=5 Participants	46 participants n=7 Participants	204 participants n=5 Participants
BMI categories 25-<30 kg/m^2	43 participants n=5 Participants	33 participants n=7 Participants	76 participants n=5 Participants
BMI categories ≥30 kg/m^2	7 participants n=5 Participants	9 participants n=7 Participants	16 participants n=5 Participants
Smoking History Never Smoked	169 participants n=5 Participants	61 participants n=7 Participants	230 participants n=5 Participants
Smoking History Current Smoker	15 participants n=5 Participants	11 participants n=7 Participants	26 participants n=5 Participants
Smoking History Ex-smoker	24 participants n=5 Participants	16 participants n=7 Participants	40 participants n=5 Participants
12-Lead Electrocardiogram (ECG) Within Normal Limits	141 participants n=5 Participants	55 participants n=7 Participants	196 participants n=5 Participants
12-Lead Electrocardiogram (ECG) Abnormal but not Clinically Significant	67 participants n=5 Participants	33 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to Week 4

Population: Full analysis set (FAS) included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable.

NERD participants were asked to keep a paper diary of daily heartburn and acid regurgitation-free days and the percentage of heartburn and acid regurgitation-free days was recorded.

Outcome measures

Measure	Dexlansoprazole 30 mg n=207 Participants Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).	Dexlansoprazole 60 mg Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
Percentage of 24-Hour Heartburn and Acid Regurgitation-Free Days in Non-Erosive Reflux Disease (NERD) Participants	26.92 percentage of days Interval 0.0 to 100.0	—

PRIMARY outcome

Timeframe: Up to Week 8

Population: FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.

EE participants were asked to keep a paper diary of daily heartburn and acid regurgitation-free days and the percentage of heartburn and acid regurgitation-free days was calculated.

Outcome measures

Measure	Dexlansoprazole 30 mg n=87 Participants Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).	Dexlansoprazole 60 mg Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
Percentage of 24-Hour Heartburn and Acid Regurgitation-Free Days in Erosive Esophagitis (EE) Participants	65.45 percentage of days Interval 0.0 to 100.0	—

SECONDARY outcome

Timeframe: Up to 4 weeks for NERD participants and up to 8 weeks for EE participants

Population: FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.

Participants were asked to keep a daily paper diary. The percentage of 24-hour heartburn free days following study drug treatments was assessed by the participant diary entries.

Outcome measures

Measure	Dexlansoprazole 30 mg n=207 Participants Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).	Dexlansoprazole 60 mg n=87 Participants Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
Percentage of 24-hour Heartburn-free Days	53.85 percentage of days Interval 0.0 to 100.0	81.97 percentage of days Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Up to 4 weeks for NERD participants and up to 8 weeks for EE participants

Population: FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.

Participants were asked to keep a daily paper diary. The percentage of 24-hour acid regurgitation-free days following study drug treatments was assessed by participant's diary entries.

Outcome measures

Measure	Dexlansoprazole 30 mg n=207 Participants Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).	Dexlansoprazole 60 mg n=88 Participants Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
Percentage of 24-hour Acid Regurgitation-free Days	75.00 percentage of days Interval 0.0 to 100.0	88.46 percentage of days Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Up to 4 weeks for NERD participants and up to 8 weeks for EE participants

Population: FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.

Participants were asked to keep a daily paper diary. The percentage of nights without nighttime heartburn and acid regurgitation in both the group was assessed by participant dairy entries.

Outcome measures

Measure	Dexlansoprazole 30 mg n=207 Participants Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).	Dexlansoprazole 60 mg n=87 Participants Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
Percentage of Nights (Participant Sleep Time) Without Nighttime Heartburn and Acid Regurgitation	59.26 percentage of nights Interval 0.0 to 100.0	83.33 percentage of nights Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Up to 4 weeks for NERD participants and up to 8 weeks for EE participants

Population: FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.

Participants were asked to keep a daily paper diary. The percentage of nights without nighttime heartburn in both the group was assessed by participant diary entries.

Outcome measures

Measure	Dexlansoprazole 30 mg n=207 Participants Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).	Dexlansoprazole 60 mg n=87 Participants Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
Percentage of Nights (Participant Sleep Time) Without Nighttime Heartburn	73.08 percentage of nights Interval 0.0 to 100.0	92.73 percentage of nights Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Up to 4 weeks for NERD participants and up to 8 weeks for EE participants

Population: FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here number of participants analyzed are the participants who were evaluable for this outcome measure.

Participants were asked to keep a daily paper diary. The percentage of nights without nighttime acid regurgitation in both the group was assessed by participant diary entries.

Outcome measures

Measure	Dexlansoprazole 30 mg n=207 Participants Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).	Dexlansoprazole 60 mg n=87 Participants Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
Percentage of Nights (Participant Sleep Time) Without Nighttime Acid Regurgitation	88.00 percentage of nights Interval 0.0 to 100.0	92.59 percentage of nights Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Up to 4 weeks for NERD participants and up to 8 weeks for EE participants

Population: FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable. Here, 'n' is the number of participants who were analyzed for GERD assessments at specified time points.

The severity of participants' GERD symptoms based on the investigator's assessment among all participants was evaluated at Week 4 or Week 8. GERD symptoms were assessed on a 5-point scale, wherein 1=no symptom, 2=mild, 3=moderate, 4=severe and 5=very severe. GERD symptoms include heartburn (HB), acid regurgitation (AR), dysphagia (dysp), belching (bch) and epigastric pain (EP).

Outcome measures

Measure	Dexlansoprazole 30 mg n=207 Participants Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).	Dexlansoprazole 60 mg n=88 Participants Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Heartburn, Very Severe	3 participants	0 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Heartburn, None	77 participants	51 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Heartburn, Mild	92 participants	21 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Heartburn, Moderate	20 participants	3 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Heartburn, Severe	6 participants	1 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Acid Regurgitation, None	97 participants	52 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Acid Regurgitation, Mild	76 participants	21 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Acid Regurgitation, Moderate	17 participants	3 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Acid Regurgitation, Severe	7 participants	0 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Acid Regurgitation, Very Severe	1 participants	0 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Dysphagia, None	169 participants	71 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Dysphagia, Mild	22 participants	5 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Dysphagia, Moderate	6 participants	0 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Dysphagia, Severe	1 participants	0 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Dysphagi, Very Severe	0 participants	0 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Belching, None	138 participants	57 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Belching, Mild	46 participants	17 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Belching, Moderate	12 participants	2 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Belching, Severe	1 participants	0 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Belching, Very Severe	1 participants	0 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Epigastric Pain, None	144 participants	58 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Epigastric Pain, Mild	42 participants	18 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Epigastric Pain, Moderate	9 participants	0 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Epigastric Pain, Severe	3 participants	0 participants
Number of Participants With Severity of Gastroesophageal Reflux Disease (GERD) Symptoms Epigastric Pain, Very Severe	0 participants	0 participants

SECONDARY outcome

Timeframe: Week 8

Population: FAS included all participants who received at least 1 dose of study drug and had post-baseline data for the appropriate efficacy variable.

Participants underwent endoscopy to determine the percentage of participants with macroscopic healing of their esophagus showing at least 1 Los Angeles (LA) grade classification grade improvement at week 8. Endoscopic findings classified according to the Los Angeles classification: Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference.

Outcome measures

Measure	Dexlansoprazole 30 mg n=88 Participants Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).	Dexlansoprazole 60 mg Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
Percentage of Participants in the EE Group Who Had Endoscopically Evaluated Macroscopic Healing of Their Esophagus	77.3 percentage of participants	—

Adverse Events

Dexlansoprazole 30 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Dexlansoprazole 60 mg

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dexlansoprazole 30 mg n=208 participants at risk Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).	Dexlansoprazole 60 mg n=88 participants at risk Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/208 • Day 1 up to 30 days after the last dose of study drug (approximately up to 12 weeks) 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.	1.1% 1/88 • Day 1 up to 30 days after the last dose of study drug (approximately up to 12 weeks) 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.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/208 • Day 1 up to 30 days after the last dose of study drug (approximately up to 12 weeks) 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.	1.1% 1/88 • Day 1 up to 30 days after the last dose of study drug (approximately up to 12 weeks) 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 30 mg n=208 participants at risk Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks to participants with non-erosive reflux disease (NERD).	Dexlansoprazole 60 mg n=88 participants at risk Dexlansoprazole 60 mg, capsules orally, once daily for up to 8 weeks to participants with erosive esophagitis (EE).
Gastrointestinal disorders Diarrhoea	0.96% 2/208 • Day 1 up to 30 days after the last dose of study drug (approximately up to 12 weeks) 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.	2.3% 2/88 • Day 1 up to 30 days after the last dose of study drug (approximately up to 12 weeks) 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.
Nervous system disorders Headache	2.4% 5/208 • Day 1 up to 30 days after the last dose of study drug (approximately up to 12 weeks) 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% 0/88 • Day 1 up to 30 days after the last dose of study drug (approximately up to 12 weeks) 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