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A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn

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ClinicalTrials.gov Identifier: NCT00627016
Recruitment Status : Completed
First Posted : February 29, 2008
Results First Posted : May 6, 2010
Last Update Posted : April 28, 2011
Sponsor:
Information provided by:
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Gastroesophageal Reflux
Interventions Drug: Dexlansoprazole
Drug: Placebo
Enrollment 305
Recruitment Details Subjects were enrolled at 33 investigative sites in the United States from 07 March 2008 to 20 March 2009.
Pre-assignment Details Subjects eligible for entry into the Treatment Period were randomized into one of two, once-daily (QD) treatment groups.
Arm/Group Title Placebo Dexlansoprazole 30 mg QD
Hide Arm/Group Description Placebo capsules, orally, once daily for up to 4 weeks. Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
Period Title: Overall Study
Started 153 152
Completed 147 146
Not Completed 6 6
Reason Not Completed
Adverse Event             1             1
Protocol Violation             0             2
Lost to Follow-up             0             1
Withdrawal by Subject             2             1
Failed Inclusion/Exclusion Criteria             0             1
Lack of Efficacy             1             0
Placed on Excluded Drugs             1             0
Pregnancy             1             0
Arm/Group Title Placebo Dexlansoprazole 30 mg QD Total
Hide Arm/Group Description Placebo capsules, orally, once daily for up to 4 weeks. Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks. Total of all reporting groups
Overall Number of Baseline Participants 153 152 305
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 153 participants 152 participants 305 participants
<45 years 75 75 150
45 to <65 years 76 75 151
>=65 years 2 2 4
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 153 participants 152 participants 305 participants
43.9  (12.45) 44.6  (11.29) 44.2  (11.87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 152 participants 305 participants
Female
98
  64.1%
97
  63.8%
195
  63.9%
Male
55
  35.9%
55
  36.2%
110
  36.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 153 participants 152 participants 305 participants
153 152 305
Number of Days with Night Heartburn   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 153 participants 152 participants 305 participants
0-3 days 10 3 13
4-5 days 36 38 74
6-7 days 107 111 218
[1]
Measure Description: Baseline diary data were summarized using the non-missing diary entries from Study Day -8 to -2, inclusive.
Number of Nights with Sleep Disturbances Related to Gastroesophageal Reflux Disease (GERD) Symptoms   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 153 participants 152 participants 305 participants
0-3 Nights 40 33 73
4-5 Nights 53 47 100
6-7 Nights 60 72 132
[1]
Measure Description: Baseline diary data were summarized using the non-missing diary entries from Study Day -8 to -2, inclusive.
1.Primary Outcome
Title Median Percentage of Nights Without Heartburn Over 4 Weeks as Assessed by Daily Diary.
Hide Description Percentage calculated by the number of heartburn-free nights out of the total number of nights during the treatment period with a diary entry indicating presence or absence of nighttime heartburn in subjects who had ≥1 diary entry indicating presence or absence of nighttime heartburn, as indicated by the subject's daily diary. Subjects indicate the presence (Yes/No) of nocturnal heartburn symptoms in a Daily Electronic Diary. Nights missing diary results were excluded from the numerator and denominator.
Time Frame 4 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on intent-to-treat subjects (randomized subjects who received at least 1 dose of study drug) who completed at least 1 diary entry for nighttime heartburn during treatment.
Arm/Group Title Placebo Dexlansoprazole 30 mg QD
Hide Arm/Group Description:
Placebo capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
Overall Number of Participants Analyzed 153 151
Median (Inter-Quartile Range)
Unit of Measure: Percentage of nights
35.7
(7.4 to 61.5)
73.1
(32.0 to 92.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dexlansoprazole 30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Statistical significance for the comparison of the primary endpoint was determined at 0.05 level.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Percent of Subjects With Relief of Night Time Heartburn Over the Last 7 Days of Treatment as Assessed by Daily Diary.
Hide Description Relief of nighttime heartburn was defined as 6 of 7 nights with no heartburn and at most 1 night with mild heartburn; lack of relief of nighttime heartburn was defined as 2 or more out of 7 nights with heartburn, or 1 night with at least moderate heartburn. Subjects indicate the presence and severity (mild, moderate, severe, or very severe) of nocturnal heartburn in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of nighttime heartburn divided by the number of subjects whose relief status could be determined.
Time Frame Last 7 days of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on intent-to-treat subjects (randomized subjects who received at least 1 dose of study drug) who had sufficient diary data to allow for determination of relief status.
Arm/Group Title Placebo Dexlansoprazole 30 mg QD
Hide Arm/Group Description:
Placebo capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
Overall Number of Participants Analyzed 148 141
Measure Type: Number
Unit of Measure: Percentage of participants
19.6 47.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dexlansoprazole 30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Statistical significance was only declared if the primary endpoint was statistically significant at 0.05 level. The multiplicity between the two secondary endpoints was adjusted by Hommel-Simes method to maintain the overall 0.05 level.
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Relief of Gastro-Esophageal Reflux Disease (GERD) Associated Sleep Disturbances Over the Last 7 Days of Treatment as Assessed by Daily Diary.
Hide Description Relief of GERD-associated sleep disturbance was defined as 6 of 7 nights with no GERD associated sleep disturbances; lack of relief of GERD-associated sleep disturbance was defined as 2 or more out of 7 nights with GERD-associated sleep disturbance. Subjects indicate the presence (Yes/No) of GERD associated sleep disturbance in a Daily Electronic Diary. The percentage was calculated as the number of subjects with relief of GERD-associated sleep disturbance divided by the number of subjects whose relief status could be determined.
Time Frame Last 7 days of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on intent-to-treat subjects (randomized subjects who received at least 1 dose of study drug) who had sufficient diary data to allow for determination of relief status.
Arm/Group Title Placebo Dexlansoprazole 30 mg QD
Hide Arm/Group Description:
Placebo capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
Overall Number of Participants Analyzed 144 142
Measure Type: Number
Unit of Measure: Percentage of participants
47.9 69.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dexlansoprazole 30 mg QD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Statistical significance was only declared if the primary endpoint was statistically significant at 0.05 level. The multiplicity between the two secondary endpoints was adjusted by Hommel-Simes method to maintain the overall 0.05 level.
Method Fisher Exact
Comments [Not Specified]
Time Frame Adverse events summarized were reported after the first dose of study drug and no more than 30 days after the last dose.
Adverse Event Reporting Description Most frequent events are those High Level Terms occurring in at least 5 % of subjects in at least one treatment group.
 
Arm/Group Title Placebo Dexlansoprazole 30 mg QD
Hide Arm/Group Description Placebo capsules, orally, once daily for up to 4 weeks. Dexlansoprazole 30 mg, capsules, orally, once daily for up to 4 weeks.
All-Cause Mortality
Placebo Dexlansoprazole 30 mg QD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Dexlansoprazole 30 mg QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/153 (0.65%)      0/152 (0.00%)    
Pregnancy, puerperium and perinatal conditions     
Abortions Spontaneous  1  1/153 (0.65%)  1 0/152 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.2)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Dexlansoprazole 30 mg QD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/153 (1.96%)      7/152 (4.61%)    
Infections and infestations     
Upper Respiratory Tract Infections  1  3/153 (1.96%)  7/152 (4.61%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.2)
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.
No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study at all study sites. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Name/Title: Sr. VP Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
Phone: 800-778-2860
Responsible Party: Sr. VP Clinical Sciences, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00627016     History of Changes
Other Study ID Numbers: T-GD07-170
U1111-1113-9537 ( Registry Identifier: WHO )
First Submitted: February 21, 2008
First Posted: February 29, 2008
Results First Submitted: March 18, 2010
Results First Posted: May 6, 2010
Last Update Posted: April 28, 2011