Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled at 105 sites in the United States; date of first dose (04 January 2006; date of last procedure: 14 November 2006).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups

	Description
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.

Participant Flow:   Overall Study

	Placebo QD	Dexlansoprazole MR 60 mg QD	Dexlansoprazole MR 90 mg QD
STARTED	140	159	152
COMPLETED	17	110	103
NOT COMPLETED	123	49	49
Adverse Event	10	6	9
Lost to Follow-up	4	3	4
Withdrawal by Subject	18	17	8
Noncompliance	0	1	2
Subject Request/Subject Unavailable	1	1	2
Relapse of Erosive Esophagitis	78	16	12
Possible Barrett's Esophagus	1	3	8
Esophageal Stricture	0	0	1
Therapeutic Failure	11	2	3

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
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.
Total	Total of all reporting groups

Baseline Measures

	Placebo QD	Dexlansoprazole MR 60 mg QD	Dexlansoprazole MR 90 mg QD	Total
Overall Participants Analyzed  [Units: Participants]	140	159	152	451
Age  [Units: Years] Mean (Standard Deviation)	48.2  (12.88)	49.7  (12.66)	48.8  (13.76)	48.9  (13.09)
Age, Customized  [Units: Participants]
<45 years	48	55	56	159
45 to <65 years	81	86	81	248
≥65 years	11	18	15	44
Gender  [Units: Participants]
Female	70	76	70	216
Male	70	83	82	235
Race (NIH/OMB)  [Units: Participants]
American Indian or Alaska Native	2	2	1	5
Asian	2	3	0	5
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	11	17	11	39
White	124	135	136	395
More than one race	1	2	4	7
Unknown or Not Reported	0	0	0	0
Ethnicity (NIH/OMB)  [Units: Participants]
Hispanic or Latino	15	19	14	48
Not Hispanic or Latino	125	140	138	403
Unknown or Not Reported	0	0	0	0
Baseline Los Angeles (LA) Classification Grade for Erosive Esophagitis (EE) [1]  [Units: Participants]
A: ≥1 mucosal break <5 mm	58	60	54	172
B: ≥1 mucosal break ≥5 mm	48	61	58	167
C: ≥1 mucosal break <75% of circumference	28	33	32	93
D: ≥1 mucosal break ≥75% of circumference	6	5	8	19
[1] Baseline values from Studies T-EE04-084 (NCT00251693)and T-EE04-085 (NCT00251719), with severity of EE increasing from Grade A to Grade D.

1.  Primary:

Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.   [ Time Frame: 6 months ]

2.  Primary:

Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method   [ Time Frame: 6 months ]

3.  Secondary:

Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.   [ Time Frame: 6 months ]

4.  Secondary:

Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.   [ Time Frame: 6 months ]

5.  Secondary:

Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.   [ Time Frame: 6 months ]

6.  Secondary:

Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.   [ Time Frame: 6 months ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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