Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00251693
First received: November 8, 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: Lansoprazole

  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 95 sites in the United States (US) and 55 ex-US sites from 02 December 2005 to 30 January 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects recorded day and nighttime heartburn symptoms and rescue medications for a screening period of up to 21 days. Subjects with endoscopically-proven erosive esophagitis (EE) at screening were enrolled in Dexlansoprazole Modified Release (MR) or Lansoprazole once daily (QD) treatment group.

Reporting Groups
  Description
Dexlansoprazole MR 60 mg QD Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
Dexlansoprazole MR 90 mg QD Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
Lansoprazole 30 mg QD Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Participant Flow:   Overall Study
    Dexlansoprazole MR 60 mg QD     Dexlansoprazole MR 90 mg QD     Lansoprazole 30 mg QD  
STARTED     680     668     690  
COMPLETED     629     624     644  
NOT COMPLETED     51     44     46  
Adverse Event                 17                 9                 9  
Protocol Violation                 2                 0                 2  
Lost to Follow-up                 12                 7                 8  
Withdrawal by Subject                 11                 17                 14  
Lack of Efficacy                 0                 1                 0  
Inclusion/exclusion criteria not met                 5                 3                 8  
Noncompliant                 0                 0                 2  
Possible Barrett's esophagus                 3                 5                 2  
Subject request/subject unavailable                 1                 2                 0  
Abnormal laboratory findings                 0                 0                 1  



  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
Dexlansoprazole MR 60 mg QD Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
Dexlansoprazole MR 90 mg QD Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
Lansoprazole 30 mg QD Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
Total Total of all reporting groups

Baseline Measures
    Dexlansoprazole MR 60 mg QD     Dexlansoprazole MR 90 mg QD     Lansoprazole 30 mg QD     Total  
Number of Participants  
[units: participants]
  680     668     690     2038  
Age, Customized  
[units: participants]
       
<45 Years     269     276     288     833  
45 Years to <65 Years     349     328     332     1009  
>=65 Years     62     64     70     196  
Age  
[units: years]
Mean ± Standard Deviation
  47.8  ± 13.71     47.3  ± 13.93     47.3  ± 13.74     47.5  ± 13.79  
Gender  
[units: participants]
       
Female     300     302     325     927  
Male     380     366     365     1111  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     60     52     54     166  
Not Hispanic or Latino     620     616     636     1872  
Unknown or Not Reported     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     6     4     7     17  
Asian     27     33     33     93  
Native Hawaiian or Other Pacific Islander     1     0     1     2  
Black or African American     32     33     27     92  
White     602     580     601     1783  
More than one race     10     15     17     42  
Unknown or Not Reported     2     3     4     9  
Los Angeles (LA) Classification Grade for Erosive Esophagitis (EE) [1]
[units: Paricipants]
       
A: ≥1 mucosal break <5mm     236     242     231     709  
B: ≥1 mucosal break ≥5mm     247     233     248     728  
C: ≥1 mucosal break and <75% of the circumference     163     148     170     481  
D: ≥1 mucosal break and ≥75% of the circumference     33     45     40     118  
Not Applicable     1     0     1     2  
[1] LA Classification for Esophagitis Grading System (grades A, B, C, D) with increasing severity from grade A to grade D.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Subjects With Complete Healing of Erosive Esophagitis (EE) by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.   [ Time Frame: 8 Weeks ]

2.  Primary:   Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.   [ Time Frame: 8 weeks ]

3.  Secondary:   Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Crude Rate Analysis.   [ Time Frame: 8 Weeks ]

4.  Secondary:   Percentage of Subjects With Baseline Erosive Esophagitis Grade C or D Combined Who Have Complete Healing of Erosive Esophagitis by Week 8 as Assessed by Endoscopy - Life Table Method.   [ Time Frame: 8 Weeks ]

5.  Secondary:   Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Crude Rate Analyses.   [ Time Frame: 4 Weeks ]

6.  Secondary:   Percentage of Subjects With Complete Healing of Erosive Esophagitis by Week 4 as Assessed by Endoscopy - Life Table Method.   [ Time Frame: 4 Weeks ]


  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:
Publications automatically indexed to this study:

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00251693     History of Changes
Other Study ID Numbers: T-EE04-084, U1111-1113-9373
Study First Received: November 8, 2005
Results First Received: February 20, 2009
Last Updated: February 1, 2012
Health Authority: United States: Food and Drug Administration