Trial Outcomes & Findings for Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis (NCT NCT00251719)
NCT ID: NCT00251719
Last Updated: 2012-02-03
Results Overview
Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed.
COMPLETED
PHASE3
2054 participants
8 Weeks
2012-02-03
Participant Flow
Subjects were enrolled at 93 sites in the US and 63 ex-US sites from 16 December 2005 to 22 January 2007.
Subjects recorded day and nighttime heartburn symptoms and rescue medications for a screening period of up to 21 days. Subjects with endoscopically-proven erosive esophagitis (EE) at screening were enrolled in Dexlansoprazole Modified Release (MR) or Lansoprazole once daily (QD) treatment group.
Participant milestones
| Measure |
Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
|
Dexlansoprazole MR 90 mg QD
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg QD
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
694
|
687
|
673
|
|
Overall Study
COMPLETED
|
641
|
642
|
643
|
|
Overall Study
NOT COMPLETED
|
53
|
45
|
30
|
Reasons for withdrawal
| Measure |
Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
|
Dexlansoprazole MR 90 mg QD
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg QD
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
14
|
8
|
7
|
|
Overall Study
Protocol Violation
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
11
|
8
|
|
Overall Study
Withdrawal by Subject
|
14
|
12
|
11
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
0
|
|
Overall Study
Inclusion/exclusion criteria not met
|
12
|
6
|
2
|
|
Overall Study
Investigator decision
|
1
|
1
|
0
|
|
Overall Study
Noncompliance
|
2
|
3
|
1
|
|
Overall Study
Barrett's esophagus
|
2
|
2
|
0
|
Baseline Characteristics
Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
Baseline characteristics by cohort
| Measure |
Dexlansoprazole MR 60 mg QD
n=694 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
|
Dexlansoprazole MR 90 mg QD
n=687 Participants
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg QD
n=673 Participants
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
|
Total
n=2054 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
LA Classification Grade
NA
|
1 participant
n=5 Participants
|
1 participant
n=7 Participants
|
0 participant
n=5 Participants
|
2 participant
n=4 Participants
|
|
Age, Customized
< 45 Years
|
255 participants
n=5 Participants
|
293 participants
n=7 Participants
|
294 participants
n=5 Participants
|
842 participants
n=4 Participants
|
|
Age, Customized
45 Years to < 65 Years
|
348 participants
n=5 Participants
|
310 participants
n=7 Participants
|
314 participants
n=5 Participants
|
972 participants
n=4 Participants
|
|
Age, Customized
>= 65 Years
|
91 participants
n=5 Participants
|
84 participants
n=7 Participants
|
65 participants
n=5 Participants
|
240 participants
n=4 Participants
|
|
Age Continuous
|
48.7 years
STANDARD_DEVIATION 13.53 • n=5 Participants
|
47.7 years
STANDARD_DEVIATION 13.80 • n=7 Participants
|
47.3 years
STANDARD_DEVIATION 13.65 • n=5 Participants
|
47.9 years
STANDARD_DEVIATION 13.66 • n=4 Participants
|
|
Sex: Female, Male
Female
|
317 Participants
n=5 Participants
|
335 Participants
n=7 Participants
|
311 Participants
n=5 Participants
|
963 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
377 Participants
n=5 Participants
|
352 Participants
n=7 Participants
|
362 Participants
n=5 Participants
|
1091 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
67 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
192 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
627 Participants
n=5 Participants
|
620 Participants
n=7 Participants
|
615 Participants
n=5 Participants
|
1862 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
33 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
598 Participants
n=5 Participants
|
588 Participants
n=7 Participants
|
584 Participants
n=5 Participants
|
1770 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
LA Classification Grade
A: ≥1 mucosal break <5 mm
|
234 participant
n=5 Participants
|
271 participant
n=7 Participants
|
222 participant
n=5 Participants
|
727 participant
n=4 Participants
|
|
LA Classification Grade
B: ≥1 mucosal break ≥5 mm
|
257 participant
n=5 Participants
|
221 participant
n=7 Participants
|
257 participant
n=5 Participants
|
735 participant
n=4 Participants
|
|
LA Classification Grade
C: ≥1 mucosal break and <75% of the circumference
|
156 participant
n=5 Participants
|
152 participant
n=7 Participants
|
150 participant
n=5 Participants
|
458 participant
n=4 Participants
|
|
LA Classification Grade
D: ≥1 mucosal break and ≥75% of the circumference
|
46 participant
n=5 Participants
|
42 participant
n=7 Participants
|
44 participant
n=5 Participants
|
132 participant
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 WeeksPopulation: Crude rate analysis were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment that was performed within 7 days of the last day of study drug.
Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A (greater than or equal to 1 mucosal break and less than 5 mm). If it doesn't meet the A criterion, it's counted as healed.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=657 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
|
Dexlansoprazole MR 90 mg QD
n=652 Participants
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg QD
n=648 Participants
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.
|
86.9 percentage of subjects
|
89.4 percentage of subjects
|
84.6 percentage of subjects
|
PRIMARY outcome
Timeframe: 8 WeeksPopulation: In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.
Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=685 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
|
Dexlansoprazole MR 90 mg QD
n=680 Participants
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg QD
n=672 Participants
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method
|
93.1 percentage of subjects
|
94.9 percentage of subjects
|
91.5 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 8Population: Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.
Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy. Change in LA Classification grades C or D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=194 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
|
Dexlansoprazole MR 90 mg QD
n=182 Participants
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg QD
n=190 Participants
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.
|
77.8 percentage of subjects
|
86.3 percentage of subjects
|
78.9 percentage of subjects
|
SECONDARY outcome
Timeframe: 8 WeeksPopulation: In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.
Percentage of subjects with baseline EE grade C or D combined who have complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades C or D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=199 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
|
Dexlansoprazole MR 90 mg QD
n=191 Participants
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg QD
n=194 Participants
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.
|
87.6 percentage of subjects
|
93.3 percentage of subjects
|
87.7 percentage of subjects
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: Crude rate analyses were performed on the ITT subjects who had at least 1 post-baseline endoscopy assessment performed within 7 days of the last day of study drug.
Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=657 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
|
Dexlansoprazole MR 90 mg QD
n=652 Participants
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg QD
n=648 Participants
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analysis.
|
69.7 percentage of subjects
|
70.6 percentage of subjects
|
65.4 percentage of subjects
|
SECONDARY outcome
Timeframe: 4 WeeksPopulation: In addition to the ITT subjects who had at least 1 post-baseline endoscopy, Life Table Method included the ITT subjects without any post-baseline endoscopy within 7 days of the last day of study drug as censored.
Percentage of subjects with complete healing of EE as assessed by endoscopy. Change in LA Esophagitis Classification grades A, B, C, D to healed was measured. Healed is defined as anything that is less than the criterion for Grade A. If it doesn't meet the A criterion, it's counted as healed.
Outcome measures
| Measure |
Dexlansoprazole MR 60 mg QD
n=685 Participants
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
|
Dexlansoprazole MR 90 mg QD
n=680 Participants
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg QD
n=672 Participants
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method
|
80.1 percentage of subjects
|
80.4 percentage of subjects
|
77.0 percentage of subjects
|
Adverse Events
Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR 90 mg QD
Lansoprazole 30 mg QD
Serious adverse events
| Measure |
Dexlansoprazole MR 60 mg QD
n=694 participants at risk
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
|
Dexlansoprazole MR 90 mg QD
n=687 participants at risk
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg QD
n=673 participants at risk
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Cardiac disorders
Ischaemic Coronary Artery Disorders
|
0.14%
1/694
|
0.15%
1/687
|
0.00%
0/673
|
|
General disorders
Pain and Discomfort not elsewhere classified (NEC)
|
0.14%
1/694
|
0.00%
0/687
|
0.00%
0/673
|
|
Hepatobiliary disorders
Cholecystitis and Cholelithiasis
|
0.00%
0/694
|
0.15%
1/687
|
0.15%
1/673
|
|
Infections and infestations
Abdominal and Gastrointestinal Infections
|
0.00%
0/694
|
0.15%
1/687
|
0.00%
0/673
|
|
Injury, poisoning and procedural complications
Non-site Specific Injuries NEC
|
0.14%
1/694
|
0.00%
0/687
|
0.00%
0/673
|
|
Injury, poisoning and procedural complications
Site Specific Injuries NEC
|
0.14%
1/694
|
0.00%
0/687
|
0.00%
0/673
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast and Nipple Neoplasms Malignant
|
0.14%
1/694
|
0.00%
0/687
|
0.00%
0/673
|
|
Nervous system disorders
Facial Cranial Nerve Disorders
|
0.00%
0/694
|
0.00%
0/687
|
0.15%
1/673
|
|
Renal and urinary disorders
Renal Lithiasis
|
0.00%
0/694
|
0.15%
1/687
|
0.00%
0/673
|
Other adverse events
| Measure |
Dexlansoprazole MR 60 mg QD
n=694 participants at risk
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
|
Dexlansoprazole MR 90 mg QD
n=687 participants at risk
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
|
Lansoprazole 30 mg QD
n=673 participants at risk
Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea (Excluding Infective)
|
4.3%
30/694
|
4.5%
31/687
|
3.4%
23/673
|
Additional Information
Sr. VP Clinical Sciences
Takeda Global Research & Development Center, Inc.
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