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Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00321984
First received: May 2, 2006
Last updated: April 25, 2011
Last verified: April 2011
Results First Received: February 26, 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
Condition: Gastroesophageal Reflux Disease
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 enrolled at 154 sites in the United States (US); date of first dose: 08 June 2006; date of last procedure: 11 December 2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects with endoscopically documented normal esophageal mucosa were enrolled in Dexlansoprazole Modified Release (MR) or Placebo once daily (QD) treatment group; subjects were instructed that lifestyle or behavioral modifications designed to treat their symptoms of gastroesophageal reflux disease (GERD) should not be altered throughout the study.

Reporting Groups
  Description
Placebo QD Placebo capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole MR 30 mg QD Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole MR 60 mg QD Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.

Participant Flow:   Overall Study
    Placebo QD   Dexlansoprazole MR 30 mg QD   Dexlansoprazole MR 60 mg QD
STARTED   317   315   315 
COMPLETED   290   294   289 
NOT COMPLETED   27   21   26 
Adverse Event                9                6                8 
Protocol Violation                0                1                1 
Lost to Follow-up                2                4                2 
Withdrawal by Subject                8                6                5 
Unmet Inclusion/Exclusion Criteria                3                1                5 
Lack of Efficacy                3                1                3 
Noncompliant                0                0                2 
Pregnancy                0                1                0 
Per Subject Request                1                0                0 
Per Investigator Request                1                0                0 
Per Sponsor Due to High Baseline Gastrin                0                1                0 



  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 4 weeks.
Dexlansoprazole MR 30 mg QD Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole MR 60 mg QD Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
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]
 317   315   315   947 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.6  (14.40)   47.6  (13.55)   47.5  (13.77)   47.5  (13.90) 
Age, Customized 
[Units: Participants]
       
<45 years   130   131   139   400 
45 to <65 years   148   149   136   433 
≥65 years   39   35   40   114 
Gender 
[Units: Participants]
       
Female   233   231   209   673 
Male   84   84   106   274 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   3   0   2   5 
Asian   5   4   7   16 
Native Hawaiian or Other Pacific Islander   3   1   0   4 
Black or African American   45   37   48   130 
White   255   267   251   773 
More than one race   4   3   6   13 
Unknown or Not Reported   2   3   1   6 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   62   67   53   182 
Not Hispanic or Latino   255   248   262   765 
Unknown or Not Reported   0   0   0   0 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median   [ Time Frame: 4 weeks ]

2.  Primary:   Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean   [ Time Frame: 4 weeks ]

3.  Secondary:   Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median   [ Time Frame: 4 weeks ]

4.  Secondary:   Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean   [ 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 & 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: Sr. VP Clinical Sciences, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00321984     History of Changes
Other Study ID Numbers: T-GD05-137
2006-000420-13 ( EudraCT Number )
U1111-1114-1935 ( Registry Identifier: WHO )
Study First Received: May 2, 2006
Results First Received: February 26, 2009
Last Updated: April 25, 2011
Health Authority: United States: Food and Drug Administration