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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 
Overall Participants Analyzed 
[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
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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: NCT00321737     History of Changes
Other Study ID Numbers: T-EE05-135
2006-000419-90 ( EudraCT Number )
U1111-1113-9433 ( Registry Identifier: WHO )
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