Trial Outcomes & Findings for Efficacy and Safety of Dexlansoprazole MR on Maintaining Healing in Subjects With Healed Erosive Esophagitis (NCT NCT00255164)
NCT ID: NCT00255164
Last Updated: 2012-02-03
Results Overview
Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
451 participants
Primary outcome timeframe
6 months
Results posted on
2012-02-03
Participant Flow
Subjects were enrolled at 105 sites in the United States; date of first dose (04 January 2006; date of last procedure: 14 November 2006).
Subjects had to have endoscopically proven healed erosive esophagitis (EE) after 4 to 8 weeks of treatment with Lansoprazole 30 mg once-daily (QD), Dexlansoprazole Modified Release (MR) 60 mg QD, or Dexlansoprazole MR 90 mg QD in the EE healing studies, T-EE04-084 (NCT00251693) and T-EE04-085 (NCT00251719).
Participant milestones
| Measure |
Placebo QD
Placebo capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 90 mg QD
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
140
|
159
|
152
|
|
Overall Study
COMPLETED
|
17
|
110
|
103
|
|
Overall Study
NOT COMPLETED
|
123
|
49
|
49
|
Reasons for withdrawal
| Measure |
Placebo QD
Placebo capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 90 mg QD
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
10
|
6
|
9
|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
18
|
17
|
8
|
|
Overall Study
Noncompliance
|
0
|
1
|
2
|
|
Overall Study
Subject Request/Subject Unavailable
|
1
|
1
|
2
|
|
Overall Study
Relapse of Erosive Esophagitis
|
78
|
16
|
12
|
|
Overall Study
Possible Barrett's Esophagus
|
1
|
3
|
8
|
|
Overall Study
Esophageal Stricture
|
0
|
0
|
1
|
|
Overall Study
Therapeutic Failure
|
11
|
2
|
3
|
Baseline Characteristics
Efficacy and Safety of Dexlansoprazole MR on Maintaining Healing in Subjects With Healed Erosive Esophagitis
Baseline characteristics by cohort
| Measure |
Placebo QD
n=140 Participants
Placebo capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 60 mg QD
n=159 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 90 mg QD
n=152 Participants
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
|
Total
n=451 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
48.2 years
STANDARD_DEVIATION 12.88 • n=5 Participants
|
49.7 years
STANDARD_DEVIATION 12.66 • n=7 Participants
|
48.8 years
STANDARD_DEVIATION 13.76 • n=5 Participants
|
48.9 years
STANDARD_DEVIATION 13.09 • n=4 Participants
|
|
Age, Customized
<45 years
|
48 participants
n=5 Participants
|
55 participants
n=7 Participants
|
56 participants
n=5 Participants
|
159 participants
n=4 Participants
|
|
Age, Customized
45 to <65 years
|
81 participants
n=5 Participants
|
86 participants
n=7 Participants
|
81 participants
n=5 Participants
|
248 participants
n=4 Participants
|
|
Age, Customized
≥65 years
|
11 participants
n=5 Participants
|
18 participants
n=7 Participants
|
15 participants
n=5 Participants
|
44 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
216 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
235 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
124 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
395 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
125 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
403 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Baseline Los Angeles (LA) Classification Grade for Erosive Esophagitis (EE)
A: ≥1 mucosal break <5 mm
|
58 participants
n=5 Participants
|
60 participants
n=7 Participants
|
54 participants
n=5 Participants
|
172 participants
n=4 Participants
|
|
Baseline Los Angeles (LA) Classification Grade for Erosive Esophagitis (EE)
B: ≥1 mucosal break ≥5 mm
|
48 participants
n=5 Participants
|
61 participants
n=7 Participants
|
58 participants
n=5 Participants
|
167 participants
n=4 Participants
|
|
Baseline Los Angeles (LA) Classification Grade for Erosive Esophagitis (EE)
C: ≥1 mucosal break <75% of circumference
|
28 participants
n=5 Participants
|
33 participants
n=7 Participants
|
32 participants
n=5 Participants
|
93 participants
n=4 Participants
|
|
Baseline Los Angeles (LA) Classification Grade for Erosive Esophagitis (EE)
D: ≥1 mucosal break ≥75% of circumference
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
19 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The crude rate analysis was performed on intent-to-treat (ITT) subjects (subjects from Studies T-EE04-084 or T-EE04-085 with endoscopically proven healed EE who received at least 1 dose of study drug in this study and did not have a gap of \>7 days between the EE healing studies and this study) with at least one endoscopy in this maintenance study.
Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.
Outcome measures
| Measure |
Placebo QD
n=112 Participants
Placebo capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 60 mg QD
n=152 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 90 mg QD
n=138 Participants
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
|
|---|---|---|---|
|
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.
|
14.3 Percentage of Subjects
Interval 8.4 to 22.2
|
66.4 Percentage of Subjects
Interval 58.3 to 73.9
|
64.5 Percentage of Subjects
Interval 55.9 to 72.4
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Life table method for the maintenance rate of healed EE was performed on ITT subjects and included subjects without post-baseline endoscopy as censored.
Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.
Outcome measures
| Measure |
Placebo QD
n=140 Participants
Placebo capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 60 mg QD
n=159 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 90 mg QD
n=152 Participants
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
|
|---|---|---|---|
|
Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method
|
25.7 Percentage of Subjects
|
86.6 Percentage of Subjects
|
82.1 Percentage of Subjects
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.
The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported.
Outcome measures
| Measure |
Placebo QD
n=133 Participants
Placebo capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 60 mg QD
n=157 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 90 mg QD
n=147 Participants
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
|
|---|---|---|---|
|
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.
|
19.2 Percentage of Days
Inter-Quartile Range 29.3 • Interval 5.0 to 52.0
|
95.8 Percentage of Days
Inter-Quartile Range 30.7 • Interval 76.9 to 99.1
|
94.4 Percentage of Days
Inter-Quartile Range 30.0 • Interval 67.1 to 99.4
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.
The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked
Outcome measures
| Measure |
Placebo QD
n=133 Participants
Placebo capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 60 mg QD
n=157 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 90 mg QD
n=147 Participants
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
|
|---|---|---|---|
|
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.
|
29.5 Percentage of Days
Standard Deviation 29.3
|
79.7 Percentage of Days
Standard Deviation 30.7
|
79.2 Percentage of Days
Standard Deviation 30.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.
The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.
Outcome measures
| Measure |
Placebo QD
n=133 Participants
Placebo capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 60 mg QD
n=157 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 90 mg QD
n=147 Participants
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
|
|---|---|---|---|
|
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.
|
50.0 Percentage of Days
Inter-Quartile Range 35.3 • Interval 14.8 to 81.3
|
98.3 Percentage of Days
Inter-Quartile Range 25.5 • Interval 90.6 to 100.0
|
97.1 Percentage of Days
Inter-Quartile Range 26.3 • Interval 83.3 to 100.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.
The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.
Outcome measures
| Measure |
Placebo QD
n=133 Participants
Placebo capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 60 mg QD
n=157 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 90 mg QD
n=147 Participants
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
|
|---|---|---|---|
|
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.
|
48.3 Percentage of Days
Standard Deviation 35.3
|
87.1 Percentage of Days
Standard Deviation 25.5
|
85.4 Percentage of Days
Standard Deviation 26.3
|
Adverse Events
Placebo QD
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Dexlansoprazole MR 60 mg QD
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
Dexlansoprazole MR 90 mg QD
Serious events: 5 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo QD
Placebo capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 90 mg QD
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
|
|---|---|---|---|
|
Cardiac disorders
Coronary Artery Disorders Not Elsewhere Classified (NEC)
|
0.00%
0/140
|
0.00%
0/159
|
0.66%
1/152
|
|
Gastrointestinal disorders
Acute and Chronic Pancreatitis
|
0.00%
0/140
|
0.00%
0/159
|
0.66%
1/152
|
|
General disorders
Pain and Discomfort NEC
|
0.00%
0/140
|
0.63%
1/159
|
0.00%
0/152
|
|
Injury, poisoning and procedural complications
Non-site Specific Injuries NEC
|
0.00%
0/140
|
0.00%
0/159
|
0.66%
1/152
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Signs and Symptoms NEC
|
0.00%
0/140
|
0.00%
0/159
|
0.66%
1/152
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast and Nipple Neoplasms Malignant
|
0.00%
0/140
|
0.00%
0/159
|
0.66%
1/152
|
|
Reproductive system and breast disorders
Uterine Disorders NEC
|
0.00%
0/140
|
0.63%
1/159
|
0.00%
0/152
|
Other adverse events
| Measure |
Placebo QD
Placebo capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 90 mg QD
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea (Excluding [Excl] Infective)
|
0.71%
1/140
|
6.3%
10/159
|
6.6%
10/152
|
|
Gastrointestinal disorders
Flatulence, Bloating and Distension
|
0.00%
0/140
|
5.0%
8/159
|
2.0%
3/152
|
|
Gastrointestinal disorders
Gastritis (Excl Infective)
|
0.71%
1/140
|
6.3%
10/159
|
3.9%
6/152
|
|
Gastrointestinal disorders
Gastrointestinal and Abdominal Pains (Excl Oral and Throat)
|
1.4%
2/140
|
6.3%
10/159
|
3.9%
6/152
|
|
Infections and infestations
Upper Respiratory Tract Infections
|
3.6%
5/140
|
2.5%
4/159
|
4.6%
7/152
|
Additional Information
Sr. VP Clinical Sciences
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. 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