This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Esophagitis, Reflux
Esophagitis, Peptic
Interventions: Drug: Dexlansoprazole MR
Drug: Lansoprazole

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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 by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00251693     History of Changes
Other Study ID Numbers: T-EE04-084
U1111-1113-9373 ( Registry Identifier: WHO )
Study First Received: November 8, 2005
Results First Received: February 20, 2009
Last Updated: February 1, 2012