Trial Outcomes & Findings for Efficacy and Safety of Dexlansoprazole on Heartburn Relief in Chinese Patients (NCT NCT02873689)
NCT ID: NCT02873689
Last Updated: 2019-07-05
Results Overview
The percentage of days with neither daytime nor nighttime heartburn was equal to (=) (the days that were heartburn-free during the treatment period) / (total number of days for which either a daytime or nighttime result was marked during treatment period)\*100 percent (%).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
217 participants
Primary outcome timeframe
Up to Week 4
Results posted on
2019-07-05
Participant Flow
Participants took part in the study at 20 investigative sites in China from 27 December 2016 to 19 April 2018.
Participants with diagnosis of symptomatic nonerosive gastroesophageal reflux disease (GERD) were enrolled in 1 of the 2 treatment groups: to receive dexlansoprazole 30 mg or placebo.
Participant milestones
| Measure |
Placebo
Dexlansoprazole placebo-matching capsule, orally, once daily for up to 4 weeks.
|
Dexlansoprazole 30 mg
Dexlansoprazole 30 mg, capsule, orally, once daily for up to 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
109
|
108
|
|
Overall Study
Treated
|
108
|
107
|
|
Overall Study
COMPLETED
|
102
|
103
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
Placebo
Dexlansoprazole placebo-matching capsule, orally, once daily for up to 4 weeks.
|
Dexlansoprazole 30 mg
Dexlansoprazole 30 mg, capsule, orally, once daily for up to 4 weeks.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Randomized but not Treated
|
1
|
1
|
Baseline Characteristics
The safety analysis set where participants for nighttime heartburn at baseline were available.
Baseline characteristics by cohort
| Measure |
Placebo
n=108 Participants
Dexlansoprazole placebo-matching capsule, orally, once daily for up to 4 weeks.
|
Dexlansoprazole 30 mg
n=107 Participants
Dexlansoprazole 30 mg, capsule, orally, once daily for up to 4 weeks.
|
Total
n=215 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.1 years
STANDARD_DEVIATION 12.73 • n=108 Participants
|
43.6 years
STANDARD_DEVIATION 13.24 • n=107 Participants
|
44.3 years
STANDARD_DEVIATION 12.98 • n=215 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=108 Participants
|
60 Participants
n=107 Participants
|
125 Participants
n=215 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=108 Participants
|
47 Participants
n=107 Participants
|
90 Participants
n=215 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=108 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=215 Participants
|
|
Race (NIH/OMB)
Asian
|
108 Participants
n=108 Participants
|
107 Participants
n=107 Participants
|
215 Participants
n=215 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=108 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=215 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=108 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=215 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=108 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=215 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=108 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=215 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=108 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=215 Participants
|
|
Region of Enrollment
China
|
108 Participants
n=108 Participants
|
107 Participants
n=107 Participants
|
215 Participants
n=215 Participants
|
|
Body mass index
|
23.935 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.4352 • n=108 Participants
|
23.701 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.5768 • n=107 Participants
|
23.819 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 3.5002 • n=215 Participants
|
|
Helicobacter pylori status
Positive
|
41 Participants
n=108 Participants
|
40 Participants
n=107 Participants
|
81 Participants
n=215 Participants
|
|
Helicobacter pylori status
Negative
|
67 Participants
n=108 Participants
|
67 Participants
n=107 Participants
|
134 Participants
n=215 Participants
|
|
Number of days with day and nighttime heartburn between study days -8 to -2
|
6.1 days
STANDARD_DEVIATION 1.27 • n=108 Participants
|
6.1 days
STANDARD_DEVIATION 1.06 • n=107 Participants
|
6.1 days
STANDARD_DEVIATION 1.17 • n=215 Participants
|
|
Number of days with nighttime heartburn between study days -8 to -2
|
5.2 days
STANDARD_DEVIATION 1.83 • n=108 Participants • The safety analysis set where participants for nighttime heartburn at baseline were available.
|
5.3 days
STANDARD_DEVIATION 1.60 • n=106 Participants • The safety analysis set where participants for nighttime heartburn at baseline were available.
|
5.2 days
STANDARD_DEVIATION 1.71 • n=214 Participants • The safety analysis set where participants for nighttime heartburn at baseline were available.
|
|
Number of days with daytime heartburn between study days -8 to -2
|
5.6 days
STANDARD_DEVIATION 1.45 • n=105 Participants • The safety analysis set where participants for daytime heartburn at baseline were available.
|
5.3 days
STANDARD_DEVIATION 1.61 • n=107 Participants • The safety analysis set where participants for daytime heartburn at baseline were available.
|
5.5 days
STANDARD_DEVIATION 1.54 • n=212 Participants • The safety analysis set where participants for daytime heartburn at baseline were available.
|
|
Severity of GERD symptoms: heartburn
None
|
0 Participants
n=108 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=215 Participants
|
|
Severity of GERD symptoms: heartburn
Mild
|
29 Participants
n=108 Participants
|
33 Participants
n=107 Participants
|
62 Participants
n=215 Participants
|
|
Severity of GERD symptoms: heartburn
Moderate
|
56 Participants
n=108 Participants
|
55 Participants
n=107 Participants
|
111 Participants
n=215 Participants
|
|
Severity of GERD symptoms: heartburn
Severe
|
22 Participants
n=108 Participants
|
17 Participants
n=107 Participants
|
39 Participants
n=215 Participants
|
|
Severity of GERD symptoms: heartburn
Very Severe
|
1 Participants
n=108 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=215 Participants
|
|
Severity of GERD symptoms: acid regurgitation
None
|
27 Participants
n=108 Participants
|
33 Participants
n=107 Participants
|
60 Participants
n=215 Participants
|
|
Severity of GERD symptoms: acid regurgitation
Mild
|
42 Participants
n=108 Participants
|
43 Participants
n=107 Participants
|
85 Participants
n=215 Participants
|
|
Severity of GERD symptoms: acid regurgitation
Moderate
|
27 Participants
n=108 Participants
|
24 Participants
n=107 Participants
|
51 Participants
n=215 Participants
|
|
Severity of GERD symptoms: acid regurgitation
Severe
|
12 Participants
n=108 Participants
|
6 Participants
n=107 Participants
|
18 Participants
n=215 Participants
|
|
Severity of GERD symptoms: acid regurgitation
Very Severe
|
0 Participants
n=108 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=215 Participants
|
|
Severity of GERD symptoms: dysphagia
None
|
101 Participants
n=108 Participants
|
103 Participants
n=107 Participants
|
204 Participants
n=215 Participants
|
|
Severity of GERD symptoms: dysphagia
Mild
|
7 Participants
n=108 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=215 Participants
|
|
Severity of GERD symptoms: dysphagia
Moderate
|
0 Participants
n=108 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=215 Participants
|
|
Severity of GERD symptoms: dysphagia
Severe
|
0 Participants
n=108 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=215 Participants
|
|
Severity of GERD symptoms: dysphagia
Very Severe
|
0 Participants
n=108 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=215 Participants
|
|
Severity of GERD symptoms: belching
None
|
59 Participants
n=108 Participants
|
62 Participants
n=107 Participants
|
121 Participants
n=215 Participants
|
|
Severity of GERD symptoms: belching
Mild
|
38 Participants
n=108 Participants
|
37 Participants
n=107 Participants
|
75 Participants
n=215 Participants
|
|
Severity of GERD symptoms: belching
Moderate
|
9 Participants
n=108 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=215 Participants
|
|
Severity of GERD symptoms: belching
Severe
|
2 Participants
n=108 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=215 Participants
|
|
Severity of GERD symptoms: belching
Very Severe
|
0 Participants
n=108 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=215 Participants
|
|
Severity of GERD symptoms: epigastric pain
None
|
95 Participants
n=108 Participants
|
88 Participants
n=107 Participants
|
183 Participants
n=215 Participants
|
|
Severity of GERD symptoms: epigastric pain
Mild
|
11 Participants
n=108 Participants
|
16 Participants
n=107 Participants
|
27 Participants
n=215 Participants
|
|
Severity of GERD symptoms: epigastric pain
Moderate
|
2 Participants
n=108 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=215 Participants
|
|
Severity of GERD symptoms: epigastric pain
Severe
|
0 Participants
n=108 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=215 Participants
|
|
Severity of GERD symptoms: epigastric pain
Very Severe
|
0 Participants
n=108 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=215 Participants
|
|
Number of days with rescue medication use
|
1.7 days
STANDARD_DEVIATION 2.68 • n=108 Participants
|
0.9 days
STANDARD_DEVIATION 1.48 • n=107 Participants
|
1.3 days
STANDARD_DEVIATION 2.19 • n=215 Participants
|
PRIMARY outcome
Timeframe: Up to Week 4Population: Full analysis set included all randomized participants who received at least 1 dose of study drug and had post-baseline (post Day-1) data for the appropriate efficacy variables.
The percentage of days with neither daytime nor nighttime heartburn was equal to (=) (the days that were heartburn-free during the treatment period) / (total number of days for which either a daytime or nighttime result was marked during treatment period)\*100 percent (%).
Outcome measures
| Measure |
Placebo
n=108 Participants
Dexlansoprazole placebo-matching capsule, orally, once daily for up to 4 weeks.
|
Dexlansoprazole 30 mg
n=107 Participants
Dexlansoprazole 30 mg, capsule, orally, once daily for up to 4 weeks.
|
|---|---|---|
|
Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment
|
32.67 percentage of days
Interval 0.0 to 100.0
|
51.72 percentage of days
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Up to Week 4Population: Full analysis set included all randomized participants who received at least 1 dose of study drug and had post-baseline (post Day-1) data for the appropriate efficacy variables.
The percentage of days without nighttime heartburn was = (the days that were heartburn-free during the treatment period) / (total number of days for which nighttime result was marked during treatment period)\*100%.
Outcome measures
| Measure |
Placebo
n=108 Participants
Dexlansoprazole placebo-matching capsule, orally, once daily for up to 4 weeks.
|
Dexlansoprazole 30 mg
n=107 Participants
Dexlansoprazole 30 mg, capsule, orally, once daily for up to 4 weeks.
|
|---|---|---|
|
Percentage of Days Without Nighttime Heartburn During Treatment
|
54.67 percentage of days
Interval 0.0 to 100.0
|
67.86 percentage of days
Interval 0.0 to 100.0
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Dexlansoprazole 30 mg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=108 participants at risk
Dexlansoprazole placebo-matching capsule, orally, once daily for up to 4 weeks.
|
Dexlansoprazole 30 mg
n=107 participants at risk
Dexlansoprazole 30 mg, capsule, orally, once daily for up to 4 weeks.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/108 • 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 the last dose of double-blind study drug (approximately Week 8).
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.
|
0.93%
1/107 • 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 the last dose of double-blind study drug (approximately Week 8).
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 |
Placebo
n=108 participants at risk
Dexlansoprazole placebo-matching capsule, orally, once daily for up to 4 weeks.
|
Dexlansoprazole 30 mg
n=107 participants at risk
Dexlansoprazole 30 mg, capsule, orally, once daily for up to 4 weeks.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
7.4%
8/108 • 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 the last dose of double-blind study drug (approximately Week 8).
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.
|
4.7%
5/107 • 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 the last dose of double-blind study drug (approximately Week 8).
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
Nasopharyngitis
|
6.5%
7/108 • 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 the last dose of double-blind study drug (approximately Week 8).
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.
|
3.7%
4/107 • 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 the last dose of double-blind study drug (approximately Week 8).
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
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