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Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00251758
First received: November 8, 2005
Last updated: May 12, 2010
Last verified: May 2010
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 157 sites in the United States (75 in Study T-GD04-082 [NCT00251745] and 82 in Study T-GD04-083 [this posting, NCT00251758]; date of first dose: 07 December 2005; date of last procedure: 23 May 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 60 mg QD Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole MR 90 mg QD Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.

Participant Flow:   Overall Study
    Placebo QD   Dexlansoprazole MR 60 mg QD   Dexlansoprazole MR 90 mg QD
STARTED   292   312   304 
COMPLETED   264   285   277 
NOT COMPLETED   28   27   27 
Adverse Event                7                9                11 
Lost to Follow-up                4                2                5 
Withdrawal by Subject                13                7                3 
Unmet Inclusion/Exclusion Criteria                0                6                5 
Lack of Efficacy                3                0                0 
Noncompliant                0                2                2 
Pregnancy                0                1                0 
Per Subject Request                0                0                1 
Per Investigator Request                1                0                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 60 mg QD Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole MR 90 mg QD Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo QD   Dexlansoprazole MR 60 mg QD   Dexlansoprazole MR 90 mg QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 292   312   304   908 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.0  (13.60)   48.0  (13.55)   46.7  (13.64)   47.9  (13.61) 
Age, Customized 
[Units: Participants]
       
<45 years   107   125   135   367 
45 - <65 years   146   155   139   440 
≥65 years   39   32   30   101 
Gender 
[Units: Participants]
       
Female   216   214   213   643 
Male   76   98   91   265 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   3   3   8   14 
Asian   9   12   7   28 
Native Hawaiian or Other Pacific Islander   1   3   0   4 
Black or African American   34   46   41   121 
White   240   246   245   731 
More than one race   5   1   3   9 
Unknown or Not Reported   0   1   0   1 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   60   58   61   179 
Not Hispanic or Latino   232   254   243   729 
Unknown or Not Reported   0   0   0   0 


  Outcome Measures
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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



Responsible Party: Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00251758     History of Changes
Other Study ID Numbers: T-GD04-083
U1111-1114-1811 ( Registry Identifier: WHO )
Study First Received: November 8, 2005
Results First Received: February 26, 2009
Last Updated: May 12, 2010
Health Authority: United States: Food and Drug Administration