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Efficacy of Dexlansoprazole MR on Heartburn Control in Participants Previously Receiving Twice Daily Proton Pump Inhibitor Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00847808
First received: February 18, 2009
Last updated: February 1, 2012
Last verified: February 2012
Results First Received: April 5, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Participant);   Primary Purpose: Treatment
Condition: Gastroesophageal Reflux
Intervention: Drug: Dexlansoprazole MR QD

  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
Participants enrolled at 45 investigative sites in the United States from 10 February 2009 to 15 April 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a diagnosis of gastroesophageal reflux disease, whose symptoms were well controlled on twice daily proton pump inhibitors, were enrolled in the study and received a once-daily (QD) dexlansoprazole modified release (MR) capsule in the morning and a matched placebo capsule in the evening.

Reporting Groups
  Description
Dexlansoprazole MR QD Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.

Participant Flow:   Overall Study
    Dexlansoprazole MR QD
STARTED   178 
COMPLETED   163 
NOT COMPLETED   15 
Adverse Event                7 
Protocol Violation                1 
Lost to Follow-up                1 
Withdrawal by Subject                4 
Participant Reported Lack of Efficacy                1 
Participant Took Excluded Medication                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 QD Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.

Baseline Measures
   Dexlansoprazole MR QD 
Overall Participants Analyzed 
[Units: Participants]
 178 
Age, Customized 
[Units: Participants]
 
<45 years   56 
45 to <65 years   94 
≥65 years   28 
Gender 
[Units: Participants]
 
Female   107 
Male   71 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Proportion of Participants Who Remain Well Controlled After Switching From Their Current Twice-daily Proton Pump Inhibitor Therapy to Dexlansoprazole MR.   [ Time Frame: Week 3 through Week 6 ]

2.  Secondary:   Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Daily Activities Subscale in Participants Who Remain Well-controlled.   [ Time Frame: Baseline and Week 6. ]

3.  Secondary:   Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Clothing Subscale in Participants Who Remain Well-controlled.   [ Time Frame: Baseline and Week 6. ]

4.  Secondary:   Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Diet and Food Habits Subscale in Participants Who Remain Well-controlled.   [ Time Frame: Baseline and Week 6. ]

5.  Secondary:   Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Relationship Subscale in Participants Who Remain Well-controlled.   [ Time Frame: Baseline and Week 6. ]

6.  Secondary:   Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Psychological Well-being Subscale in Participants Who Remain Well-controlled.   [ Time Frame: Baseline and Week 6. ]

7.  Secondary:   Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Total Score in Participants Who Remain Well-controlled.   [ Time Frame: Baseline and Week 6. ]

8.  Secondary:   Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Nausea/Vomiting Subscale in Participants Who Remain Well-controlled.   [ Time Frame: Baseline and Week 6. ]

9.  Secondary:   Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Fullness/Early Satiety Subscale in Participants Who Remain Well-controlled.   [ Time Frame: Baseline and Week 6. ]

10.  Secondary:   Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Bloating Subscale in Participants Who Remain Well-controlled.   [ Time Frame: Baseline and Week 6. ]

11.  Secondary:   Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Upper Abdominal Pain Subscale in Participants Who Remain Well-controlled.   [ Time Frame: Baseline and Week 6. ]

12.  Secondary:   Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Lower Abdominal Pain Subscale in Participants Who Remain Well-controlled.   [ Time Frame: Baseline and Week 6. ]

13.  Secondary:   Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Heartburn/Regurgitation Subscale in Participants Who Remain Well-controlled.   [ Time Frame: Baseline and Week 6. ]

14.  Secondary:   Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Total Score in Participants Who Remain Well-controlled.   [ Time Frame: Baseline and Week 6. ]


  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 Science
Organization: Takeda Global Research and Development Center, Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00847808     History of Changes
Other Study ID Numbers: T-GD08-178
U1111-1112-1761 ( Registry Identifier: WHO )
Study First Received: February 18, 2009
Results First Received: April 5, 2011
Last Updated: February 1, 2012