Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00321737
First received: May 2, 2006
Last updated: February 1, 2012
Last verified: February 2012
Results First Received: February 20, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Esophagitis, Reflux
Esophagitis, Peptic
Interventions: Drug: Dexlansoprazole MR
Drug: Placebo

  Participant Flow
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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 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).

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 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.

Participant Flow:   Overall Study
    Placebo QD     Dexlansoprazole MR 30 mg QD     Dexlansoprazole MR 60 mg QD  
STARTED     147     140     158  
COMPLETED     25     92     104  
NOT COMPLETED     122     48     54  
Relapse of Erosive Esophagitis                 76                 25                 19  
Adverse Event                 11                 3                 6  
Lost to Follow-up                 5                 5                 6  
Withdrawal by Subject                 19                 12                 17  
Protocol Violation                 0                 0                 1  
Unmet Inclusion/Exclusion Criteria                 1                 0                 0  
Possible Barrett's Esophagus                 2                 1                 1  
Therapeutic Failure                 6                 0                 2  
Pregnancy                 0                 2                 0  
Noncompliance                 2                 0                 0  
Subject Request/ Subject Unavailable                 0                 0                 2  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    Placebo QD     Dexlansoprazole MR 30 mg QD     Dexlansoprazole MR 60 mg QD     Total  
Number of Participants  
[units: participants]
  147     140     158     445  
Age  
[units: years]
Mean ± Standard Deviation
  49.5  ± 12.94     47.1  ± 13.15     47.9  ± 11.72     48.2  ± 12.60  
Age, Customized  
[units: participants]
       
<45 years     50     54     58     162  
45 - <65 years     83     75     89     247  
≥65 years     14     11     11     36  
Gender  
[units: participants]
       
Female     75     71     84     230  
Male     72     69     74     215  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     4     4  
Asian     3     3     5     11  
Native Hawaiian or Other Pacific Islander     0     0     1     1  
Black or African American     4     6     11     21  
White     138     127     135     400  
More than one race     1     4     2     7  
Unknown or Not Reported     1     0     0     1  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     20     21     19     60  
Not Hispanic or Latino     127     119     139     385  
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     51     53     56     160  
B: ≥1 mucosal break ≥5 mm     57     46     57     160  
C: ≥1 mucosal break <75% of circumference     34     31     39     104  
D: ≥1 mucosal break ≥75% of circumference     5     10     6     21  
[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.



  Outcome Measures
  Show All Outcome Measures

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  More Information
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Certain Agreements:  
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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Sr. VP Clinical Sciences
Organization: Takeda Global Research and Development Center, Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com


Publications of Results:

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00321737     History of Changes
Other Study ID Numbers: T-EE05-135, 2006-000419-90, U1111-1113-9433
Study First Received: May 2, 2006
Results First Received: February 20, 2009
Last Updated: February 1, 2012
Health Authority: United States: Food and Drug Administration