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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00255164
First received: November 15, 2005
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 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  



  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 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  
Number of Participants  
[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.



  Outcome Measures
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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: NCT00255164     History of Changes
Other Study ID Numbers: T-EE04-086, U1111-1114-1355
Study First Received: November 15, 2005
Results First Received: February 20, 2009
Last Updated: February 1, 2012
Health Authority: United States: Food and Drug Administration