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  
Number of Participants  
[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
  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


No publications provided


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
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