Trial Outcomes & Findings for A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn (NCT NCT00627016)

Last Updated: 2011-04-28

Results Overview

Percentage calculated by the number of heartburn-free nights out of the total number of nights during the treatment period with a diary entry indicating presence or absence of nighttime heartburn in subjects who had ≥1 diary entry indicating presence or absence of nighttime heartburn, as indicated by the subject's daily diary. Subjects indicate the presence (Yes/No) of nocturnal heartburn symptoms in a Daily Electronic Diary. Nights missing diary results were excluded from the numerator and denominator.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

305 participants

Primary outcome timeframe

4 Weeks

Results posted on

2011-04-28

Participant Flow

Subjects were enrolled at 33 investigative sites in the United States from 07 March 2008 to 20 March 2009.

Subjects eligible for entry into the Treatment Period were randomized into one of two, once-daily (QD) treatment groups.

Participant milestones

Participant milestones
Measure	Placebo Placebo capsules, orally, once daily for up to 4 weeks.	Dexlansoprazole 30 mg QD Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
Overall Study STARTED	153	152
Overall Study COMPLETED	147	146
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo capsules, orally, once daily for up to 4 weeks.	Dexlansoprazole 30 mg QD Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
Overall Study Adverse Event	1	1
Overall Study Protocol Violation	0	2
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	2	1
Overall Study Failed Inclusion/Exclusion Criteria	0	1
Overall Study Lack of Efficacy	1	0
Overall Study Placed on Excluded Drugs	1	0
Overall Study Pregnancy	1	0

Baseline Characteristics

A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=153 Participants Placebo capsules, orally, once daily for up to 4 weeks.	Dexlansoprazole 30 mg QD n=152 Participants Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.	Total n=305 Participants Total of all reporting groups
Age, Customized <45 years	75 participants n=5 Participants	75 participants n=7 Participants	150 participants n=5 Participants
Age, Customized 45 to <65 years	76 participants n=5 Participants	75 participants n=7 Participants	151 participants n=5 Participants
Age, Customized >=65 years	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Age Continuous	43.9 years STANDARD_DEVIATION 12.45 • n=5 Participants	44.6 years STANDARD_DEVIATION 11.29 • n=7 Participants	44.2 years STANDARD_DEVIATION 11.87 • n=5 Participants
Sex: Female, Male Female	98 Participants n=5 Participants	97 Participants n=7 Participants	195 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	55 Participants n=7 Participants	110 Participants n=5 Participants
Region of Enrollment United States	153 participants n=5 Participants	152 participants n=7 Participants	305 participants n=5 Participants
Number of Days with Night Heartburn 0-3 days	10 participants n=5 Participants	3 participants n=7 Participants	13 participants n=5 Participants
Number of Days with Night Heartburn 4-5 days	36 participants n=5 Participants	38 participants n=7 Participants	74 participants n=5 Participants
Number of Days with Night Heartburn 6-7 days	107 participants n=5 Participants	111 participants n=7 Participants	218 participants n=5 Participants
Number of Nights with Sleep Disturbances Related to Gastroesophageal Reflux Disease (GERD) Symptoms 0-3 Nights	40 participants n=5 Participants	33 participants n=7 Participants	73 participants n=5 Participants
Number of Nights with Sleep Disturbances Related to Gastroesophageal Reflux Disease (GERD) Symptoms 4-5 Nights	53 participants n=5 Participants	47 participants n=7 Participants	100 participants n=5 Participants
Number of Nights with Sleep Disturbances Related to Gastroesophageal Reflux Disease (GERD) Symptoms 6-7 Nights	60 participants n=5 Participants	72 participants n=7 Participants	132 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 Weeks

Population: Analysis was conducted on intent-to-treat subjects (randomized subjects who received at least 1 dose of study drug) who completed at least 1 diary entry for nighttime heartburn during treatment.

Outcome measures

Outcome measures
Measure	Placebo n=153 Participants Placebo capsules, orally, once daily for up to 4 weeks.	Dexlansoprazole 30 mg QD n=151 Participants Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
Median Percentage of Nights Without Heartburn Over 4 Weeks as Assessed by Daily Diary.	35.7 Percentage of nights Inter-Quartile Range 30.0 • Interval 7.4 to 61.5	73.1 Percentage of nights Inter-Quartile Range 35.0 • Interval 32.0 to 92.3

SECONDARY outcome

Timeframe: Last 7 days of treatment

Population: Analysis was conducted on intent-to-treat subjects (randomized subjects who received at least 1 dose of study drug) who had sufficient diary data to allow for determination of relief status.

Relief of nighttime heartburn was defined as 6 of 7 nights with no heartburn and at most 1 night with mild heartburn; lack of relief of nighttime heartburn was defined as 2 or more out of 7 nights with heartburn, or 1 night with at least moderate heartburn. Subjects indicate the presence and severity (mild, moderate, severe, or very severe) of nocturnal heartburn in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of nighttime heartburn divided by the number of subjects whose relief status could be determined.

Outcome measures

Outcome measures
Measure	Placebo n=148 Participants Placebo capsules, orally, once daily for up to 4 weeks.	Dexlansoprazole 30 mg QD n=141 Participants Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
Percent of Subjects With Relief of Night Time Heartburn Over the Last 7 Days of Treatment as Assessed by Daily Diary.	19.6 Percentage of participants	47.5 Percentage of participants

SECONDARY outcome

Timeframe: Last 7 days of treatment

Relief of GERD-associated sleep disturbance was defined as 6 of 7 nights with no GERD associated sleep disturbances; lack of relief of GERD-associated sleep disturbance was defined as 2 or more out of 7 nights with GERD-associated sleep disturbance. Subjects indicate the presence (Yes/No) of GERD associated sleep disturbance in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of GERD-associated sleep disturbance divided by the number of subjects whose relief status could be determined.

Outcome measures

Outcome measures
Measure	Placebo n=144 Participants Placebo capsules, orally, once daily for up to 4 weeks.	Dexlansoprazole 30 mg QD n=142 Participants Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
Percentage of Participants With Relief of Gastro-Esophageal Reflux Disease (GERD) Associated Sleep Disturbances Over the Last 7 Days of Treatment as Assessed by Daily Diary.	47.9 Percentage of participants 29.9	69.7 Percentage of participants 29.6

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Dexlansoprazole 30 mg QD

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=153 participants at risk Placebo capsules, orally, once daily for up to 4 weeks.	Dexlansoprazole 30 mg QD n=152 participants at risk Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
Pregnancy, puerperium and perinatal conditions Abortions Spontaneous	0.65% 1/153 • Number of events 1 • Adverse events summarized were reported after the first dose of study drug and no more than 30 days after the last dose. Most frequent events are those High Level Terms occurring in at least 5 % of subjects in at least one treatment group.	0.00% 0/152 • Adverse events summarized were reported after the first dose of study drug and no more than 30 days after the last dose. Most frequent events are those High Level Terms occurring in at least 5 % of subjects in at least one treatment group.

Other adverse events

Other adverse events
Measure	Placebo n=153 participants at risk Placebo capsules, orally, once daily for up to 4 weeks.	Dexlansoprazole 30 mg QD n=152 participants at risk Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
Infections and infestations Upper Respiratory Tract Infections	2.0% 3/153 • Adverse events summarized were reported after the first dose of study drug and no more than 30 days after the last dose. Most frequent events are those High Level Terms occurring in at least 5 % of subjects in at least one treatment group.	4.6% 7/152 • Adverse events summarized were reported after the first dose of study drug and no more than 30 days after the last dose. Most frequent events are those High Level Terms occurring in at least 5 % of subjects in at least one treatment group.

Additional Information

Sr. VP Clinical Science

Takeda Global Research and Development Center, Inc.

Phone: 800-778-2860

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER