Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis
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ClinicalTrials.gov Identifier: NCT00255151 |
Recruitment Status :
Completed
First Posted : November 17, 2005
Results First Posted : August 28, 2009
Last Update Posted : February 3, 2012
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Sponsor:
Takeda
Information provided by (Responsible Party):
Takeda
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Conditions |
Esophagitis, Reflux Esophagitis, Peptic |
Interventions |
Drug: Dexlansoprazole MR Drug: Placebo |
Enrollment | 451 |
Participant Flow
Recruitment Details | 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 | 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). |
Arm/Group Title | Placebo QD | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 90 mg QD |
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Placebo capsules, orally, once daily for up to 6 months. | Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months. | Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months. |
Period Title: Overall Study | |||
Started | 140 | 159 | 152 |
Completed | 17 | 110 | 103 |
Not Completed | 123 | 49 | 49 |
Reason Not Completed | |||
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 |
Baseline Characteristics
Arm/Group Title | Placebo QD | Dexlansoprazole MR 60 mg QD | Dexlansoprazole MR 90 mg QD | Total | |
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Placebo capsules, orally, once daily for up to 6 months. | Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months. | Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months. | Total of all reporting groups | |
Overall Number of Baseline Participants | 140 | 159 | 152 | 451 | |
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[Not Specified]
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 140 participants | 159 participants | 152 participants | 451 participants | |
48.2 (12.88) | 49.7 (12.66) | 48.8 (13.76) | 48.9 (13.09) | ||
Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 140 participants | 159 participants | 152 participants | 451 participants |
<45 years | 48 | 55 | 56 | 159 | |
45 to <65 years | 81 | 86 | 81 | 248 | |
≥65 years | 11 | 18 | 15 | 44 | |
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 140 participants | 159 participants | 152 participants | 451 participants | |
Female |
70 50.0%
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76 47.8%
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70 46.1%
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216 47.9%
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Male |
70 50.0%
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83 52.2%
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82 53.9%
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235 52.1%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 140 participants | 159 participants | 152 participants | 451 participants | |
American Indian or Alaska Native |
2 1.4%
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2 1.3%
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1 0.7%
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5 1.1%
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Asian |
2 1.4%
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3 1.9%
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0 0.0%
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5 1.1%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
11 7.9%
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17 10.7%
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11 7.2%
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39 8.6%
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White |
124 88.6%
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135 84.9%
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136 89.5%
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395 87.6%
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More than one race |
1 0.7%
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2 1.3%
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4 2.6%
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7 1.6%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 140 participants | 159 participants | 152 participants | 451 participants | |
Hispanic or Latino |
15 10.7%
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19 11.9%
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14 9.2%
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48 10.6%
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Not Hispanic or Latino |
125 89.3%
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140 88.1%
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138 90.8%
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403 89.4%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Baseline Los Angeles (LA) Classification Grade for Erosive Esophagitis (EE)
[1] Measure Type: Number Unit of measure: Participants |
Number Analyzed | 140 participants | 159 participants | 152 participants | 451 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]
Measure Description: Baseline values from Studies T-EE04-084 (NCT00251693)and T-EE04-085 (NCT00251719), with severity of EE increasing from Grade A to Grade D.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: | Sr. VP Clinical Sciences |
Organization: | Takeda Global Research and Development Center, Inc. |
Phone: | 800-778-2860 |
EMail: | clinicaltrialregistry@tpna.com |
Responsible Party: | Takeda |
ClinicalTrials.gov Identifier: | NCT00255151 |
Other Study ID Numbers: |
T-EE04-087 U1111-1114-1767 ( Registry Identifier: WHO ) |
First Submitted: | November 15, 2005 |
First Posted: | November 17, 2005 |
Results First Submitted: | February 20, 2009 |
Results First Posted: | August 28, 2009 |
Last Update Posted: | February 3, 2012 |