Trial Outcomes & Findings for Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis (NCT NCT00321737)
NCT ID: NCT00321737
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
445 participants
Primary outcome timeframe
6 months
Results posted on
2012-02-03
Participant Flow
Subjects were enrolled at a total of 94 sites: 75 sites in the United States and 19 sites in Australia, Canada, the Czech Republic, Estonia, India, Latvia, Lithuania, Poland, and the Slovak Republic (date of first dose: 19 May 2006; date of last procedure: 21 May 2007).
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 30 mg QD
Dexlansoprazole MR 30 mg, 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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
147
|
140
|
158
|
|
Overall Study
COMPLETED
|
25
|
92
|
104
|
|
Overall Study
NOT COMPLETED
|
122
|
48
|
54
|
Reasons for withdrawal
| Measure |
Placebo QD
Placebo capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 30 mg QD
Dexlansoprazole MR 30 mg, 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.
|
|---|---|---|---|
|
Overall Study
Relapse of Erosive Esophagitis
|
76
|
25
|
19
|
|
Overall Study
Adverse Event
|
11
|
3
|
6
|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
6
|
|
Overall Study
Withdrawal by Subject
|
19
|
12
|
17
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Unmet Inclusion/Exclusion Criteria
|
1
|
0
|
0
|
|
Overall Study
Possible Barrett's Esophagus
|
2
|
1
|
1
|
|
Overall Study
Therapeutic Failure
|
6
|
0
|
2
|
|
Overall Study
Pregnancy
|
0
|
2
|
0
|
|
Overall Study
Noncompliance
|
2
|
0
|
0
|
|
Overall Study
Subject Request/ Subject Unavailable
|
0
|
0
|
2
|
Baseline Characteristics
Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis
Baseline characteristics by cohort
| Measure |
Placebo QD
n=147 Participants
Placebo capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 30 mg QD
n=140 Participants
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 60 mg QD
n=158 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
|
Total
n=445 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
49.5 years
STANDARD_DEVIATION 12.94 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 13.15 • n=7 Participants
|
47.9 years
STANDARD_DEVIATION 11.72 • n=5 Participants
|
48.2 years
STANDARD_DEVIATION 12.60 • n=4 Participants
|
|
Age, Customized
<45 years
|
50 participants
n=5 Participants
|
54 participants
n=7 Participants
|
58 participants
n=5 Participants
|
162 participants
n=4 Participants
|
|
Age, Customized
45 - <65 years
|
83 participants
n=5 Participants
|
75 participants
n=7 Participants
|
89 participants
n=5 Participants
|
247 participants
n=4 Participants
|
|
Age, Customized
≥65 years
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
11 participants
n=5 Participants
|
36 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
230 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
215 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
138 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
400 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
127 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
385 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
|
51 participants
n=5 Participants
|
53 participants
n=7 Participants
|
56 participants
n=5 Participants
|
160 participants
n=4 Participants
|
|
Baseline Los Angeles (LA) Classification Grade for Erosive Esophagitis (EE)
B: ≥1 mucosal break ≥5 mm
|
57 participants
n=5 Participants
|
46 participants
n=7 Participants
|
57 participants
n=5 Participants
|
160 participants
n=4 Participants
|
|
Baseline Los Angeles (LA) Classification Grade for Erosive Esophagitis (EE)
C: ≥1 mucosal break <75% of circumference
|
34 participants
n=5 Participants
|
31 participants
n=7 Participants
|
39 participants
n=5 Participants
|
104 participants
n=4 Participants
|
|
Baseline Los Angeles (LA) Classification Grade for Erosive Esophagitis (EE)
D: ≥1 mucosal break ≥75% of circumference
|
5 participants
n=5 Participants
|
10 participants
n=7 Participants
|
6 participants
n=5 Participants
|
21 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=119 Participants
Placebo capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 30 mg QD
n=125 Participants
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 60 mg QD
n=143 Participants
Dexlansoprazole MR 60 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
|
66.4 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=145 Participants
Placebo capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 30 mg QD
n=137 Participants
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 60 mg QD
n=153 Participants
Dexlansoprazole MR 60 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
|
27.2 Percentage of Subjects
|
74.9 Percentage of Subjects
|
82.5 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=141 Participants
Placebo capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 30 mg QD
n=132 Participants
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 60 mg QD
n=147 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
|
|---|---|---|---|
|
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.
|
28.6 Percentage of Days
Inter-Quartile Range 32.0 • Interval 5.9 to 61.8
|
96.1 Percentage of Days
Inter-Quartile Range 26.5 • Interval 80.7 to 100.0
|
90.9 Percentage of Days
Inter-Quartile Range 28.3 • Interval 66.7 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=141 Participants
Placebo capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 30 mg QD
n=132 Participants
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 60 mg QD
n=147 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
|
|---|---|---|---|
|
Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.
|
36.0 Percentage of Days
Standard Deviation 32.0
|
83.3 Percentage of Days
Standard Deviation 26.5
|
78.4 Percentage of Days
Standard Deviation 28.3
|
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=140 Participants
Placebo capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 30 mg QD
n=132 Participants
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 60 mg QD
n=147 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
|
|---|---|---|---|
|
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.
|
71.7 Percentage of Days
Inter-Quartile Range 36.6 • Interval 19.5 to 92.2
|
98.9 Percentage of Days
Inter-Quartile Range 22.3 • Interval 90.9 to 100.0
|
96.2 Percentage of Days
Inter-Quartile Range 23.1 • Interval 80.0 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=140 Participants
Placebo capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 30 mg QD
n=132 Participants
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 60 mg QD
n=147 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
|
|---|---|---|---|
|
Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.
|
57.7 Percentage of Days
Standard Deviation 36.6
|
89.3 Percentage of Days
Standard Deviation 22.3
|
86.0 Percentage of Days
Standard Deviation 23.1
|
Adverse Events
Placebo QD
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Dexlansoprazole MR 30 mg QD
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Dexlansoprazole MR 60 mg QD
Serious events: 6 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo QD
Placebo capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 30 mg QD
Dexlansoprazole MR 30 mg, 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.
|
|---|---|---|---|
|
General disorders
Implant and Catheter Site Reactions
|
0.00%
0/147
|
0.00%
0/140
|
0.63%
1/158
|
|
General disorders
Pain and Discomfort Not Elsewhere Classified (NEC)
|
0.00%
0/147
|
0.00%
0/140
|
0.63%
1/158
|
|
Hepatobiliary disorders
Cholecystitis and Cholelithiasis
|
0.00%
0/147
|
0.00%
0/140
|
0.63%
1/158
|
|
Infections and infestations
Bacterial Infections NEC
|
0.00%
0/147
|
0.00%
0/140
|
0.63%
1/158
|
|
Infections and infestations
Viral Infections NEC
|
0.00%
0/147
|
0.00%
0/140
|
0.63%
1/158
|
|
Injury, poisoning and procedural complications
Limb Injuries NEC (Including [Incl] Traumatic Amputation)
|
0.00%
0/147
|
0.00%
0/140
|
0.63%
1/158
|
|
Injury, poisoning and procedural complications
Non-Site Specific Injuries NEC
|
0.00%
0/147
|
0.00%
0/140
|
0.63%
1/158
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic Neoplasms Malignant
|
0.00%
0/147
|
0.71%
1/140
|
0.00%
0/158
|
|
Nervous system disorders
Cerebrovascular Venous and Sinus Thrombosis
|
0.00%
0/147
|
0.00%
0/140
|
0.63%
1/158
|
|
Nervous system disorders
Migraine Headaches
|
0.00%
0/147
|
0.00%
0/140
|
0.63%
1/158
|
|
Pregnancy, puerperium and perinatal conditions
Abortions Spontaneous
|
0.68%
1/147
|
0.71%
1/140
|
0.00%
0/158
|
|
Reproductive system and breast disorders
Ovarian And Fallopian Tube Cysts and Neoplasms
|
0.00%
0/147
|
0.00%
0/140
|
0.63%
1/158
|
|
Reproductive system and breast disorders
Uterine Disorders NEC
|
0.00%
0/147
|
0.00%
0/140
|
0.63%
1/158
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm and Obstruction
|
0.00%
0/147
|
0.00%
0/140
|
0.63%
1/158
|
|
Vascular disorders
Peripheral Embolism and Thrombosis
|
0.00%
0/147
|
0.00%
0/140
|
0.63%
1/158
|
Other adverse events
| Measure |
Placebo QD
Placebo capsules, orally, once daily for up to 6 months.
|
Dexlansoprazole MR 30 mg QD
Dexlansoprazole MR 30 mg, 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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea (Excluding [Excl] Infective)
|
0.68%
1/147
|
3.6%
5/140
|
5.1%
8/158
|
|
Gastrointestinal disorders
Gastritis (Excl Infective)
|
4.8%
7/147
|
1.4%
2/140
|
5.1%
8/158
|
|
Infections and infestations
Upper Respiratory Tract Infections
|
0.68%
1/147
|
10.0%
14/140
|
10.8%
17/158
|
|
Musculoskeletal and connective tissue disorders
Joint Related Signs and Symptoms
|
0.68%
1/147
|
5.0%
7/140
|
0.00%
0/158
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Signs and Symptoms NEC
|
1.4%
2/147
|
2.1%
3/140
|
5.1%
8/158
|
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