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

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ClinicalTrials.gov Identifier: NCT00321984
Recruitment Status : Completed
First Posted : May 4, 2006
Results First Posted : March 23, 2009
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 Disease
Interventions Drug: Dexlansoprazole MR
Drug: Placebo
Enrollment 947
Recruitment Details 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 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.
Arm/Group Title Placebo QD Dexlansoprazole MR 30 mg QD Dexlansoprazole MR 60 mg QD
Hide Arm/Group Description Placebo capsules, orally, once daily for up to 4 weeks. Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks. Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
Period Title: Overall Study
Started 317 315 315
Completed 290 294 289
Not Completed 27 21 26
Reason Not Completed
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
Arm/Group Title Placebo QD Dexlansoprazole MR 30 mg QD Dexlansoprazole MR 60 mg QD Total
Hide Arm/Group Description Placebo capsules, orally, once daily for up to 4 weeks. Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks. Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks. Total of all reporting groups
Overall Number of Baseline Participants 317 315 315 947
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 317 participants 315 participants 315 participants 947 participants
47.6  (14.40) 47.6  (13.55) 47.5  (13.77) 47.5  (13.90)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 317 participants 315 participants 315 participants 947 participants
<45 years 130 131 139 400
45 to <65 years 148 149 136 433
≥65 years 39 35 40 114
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 317 participants 315 participants 315 participants 947 participants
Female
233
  73.5%
231
  73.3%
209
  66.3%
673
  71.1%
Male
84
  26.5%
84
  26.7%
106
  33.7%
274
  28.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 317 participants 315 participants 315 participants 947 participants
American Indian or Alaska Native
3
   0.9%
0
   0.0%
2
   0.6%
5
   0.5%
Asian
5
   1.6%
4
   1.3%
7
   2.2%
16
   1.7%
Native Hawaiian or Other Pacific Islander
3
   0.9%
1
   0.3%
0
   0.0%
4
   0.4%
Black or African American
45
  14.2%
37
  11.7%
48
  15.2%
130
  13.7%
White
255
  80.4%
267
  84.8%
251
  79.7%
773
  81.6%
More than one race
4
   1.3%
3
   1.0%
6
   1.9%
13
   1.4%
Unknown or Not Reported
2
   0.6%
3
   1.0%
1
   0.3%
6
   0.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 317 participants 315 participants 315 participants 947 participants
Hispanic or Latino
62
  19.6%
67
  21.3%
53
  16.8%
182
  19.2%
Not Hispanic or Latino
255
  80.4%
248
  78.7%
262
  83.2%
765
  80.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
Hide Description The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett’s esophagus and/or definite dysplastic changes.
Arm/Group Title Placebo QD Dexlansoprazole MR 30 mg QD Dexlansoprazole MR 60 mg QD
Hide Arm/Group Description:
Placebo capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
Overall Number of Participants Analyzed 310 312 307
Median (Inter-Quartile Range)
Unit of Measure: percentage of days
18.5
(0.0 to 42.9)
54.9
(19.7 to 80.9)
50.0
(14.8 to 80.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Dexlansoprazole MR 30 mg QD
Comments The comparison between the two treatment groups was made using Wilcoxon rank-sum test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.00001
Comments The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg’s method.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Dexlansoprazole MR 60 mg QD
Comments The comparison between the two treatment groups was made using Wilcoxon rank-sum test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.00001
Comments The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg’s method.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Dexlansoprazole MR 30 mg QD, Dexlansoprazole MR 60 mg QD
Comments The comparison between the two treatment groups was made using Wilcoxon rank-sum test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72941
Comments Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Percentage of Days With Neither Daytime Nor Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
Hide Description The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on an intent-to-treat (ITT) population that included all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment. All ITT populations excluded subjects with confirmed Barrett’s esophagus and/or definite dysplastic changes.
Arm/Group Title Placebo QD Dexlansoprazole MR 30 mg QD Dexlansoprazole MR 60 mg QD
Hide Arm/Group Description:
Placebo capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
Overall Number of Participants Analyzed 310 312 307
Mean (Standard Deviation)
Unit of Measure: percentage of days
25.0  (25.6) 50.3  (33.9) 49.1  (34.7)
3.Secondary Outcome
Title Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Median
Hide Description The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.
Arm/Group Title Placebo QD Dexlansoprazole MR 30 mg QD Dexlansoprazole MR 60 mg QD
Hide Arm/Group Description:
Placebo capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
Overall Number of Participants Analyzed 308 311 307
Median (Inter-Quartile Range)
Unit of Measure: percentage of days
51.7
(16.3 to 74.3)
80.8
(45.8 to 95.8)
76.9
(43.3 to 94.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo QD, Dexlansoprazole MR 30 mg QD
Comments The comparison between the two treatment groups was made using Wilcoxon rank-sum test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.00001
Comments The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg’s method.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Dexlansoprazole MR 60 mg QD
Comments The comparison between the two treatment groups was made using Wilcoxon rank-sum test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.00001
Comments The overall 0.0025 level of significance for the multiple comparisons of each dexlansoprazole MR dose to placebo was controlled using Hochberg’s method.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Dexlansoprazole MR 30 mg QD, Dexlansoprazole MR 60 mg QD
Comments The comparison between the two treatment groups was made using Wilcoxon rank-sum test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31460
Comments Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Days Without Nighttime Heartburn During Treatment as Assessed by Daily Electronic Diary-Mean
Hide Description The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was conducted on an ITT population (all randomized subjects who received at least 1 dose of study drug and completed at least 1 diary entry for heartburn during treatment), but excluded subjects without any morning diary entries on Day 1 or later.
Arm/Group Title Placebo QD Dexlansoprazole MR 30 mg QD Dexlansoprazole MR 60 mg QD
Hide Arm/Group Description:
Placebo capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
Overall Number of Participants Analyzed 308 311 307
Mean (Standard Deviation)
Unit of Measure: percentage of days
47.1  (32.6) 67.6  (34.1) 65.0  (34.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo QD Dexlansoprazole MR 30 mg QD Dexlansoprazole MR 60 mg QD
Hide Arm/Group Description Placebo capsules, orally, once daily for up to 4 weeks. Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks. Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
All-Cause Mortality
Placebo QD Dexlansoprazole MR 30 mg QD Dexlansoprazole MR 60 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo QD Dexlansoprazole MR 30 mg QD Dexlansoprazole MR 60 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1   2   1 
Cardiac disorders       
Coronary Artery Disorders Not Elsewhere Classified (NEC)  1  1/317 (0.32%)  0/315 (0.00%)  0/315 (0.00%) 
Ischaemic Coronary Artery Disorders  1  0/317 (0.00%)  2/315 (0.63%)  0/315 (0.00%) 
Heart Failures NEC  1  0/317 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Gastrointestinal disorders       
Gastrointestinal & Abdominal Pains (Excluding Oral and Throat)  1  0/317 (0.00%)  0/315 (0.00%)  1/315 (0.32%) 
Non-site Specific Gastrointestinal Haemorrhages  1  0/317 (0.00%)  0/315 (0.00%)  1/315 (0.32%) 
Infections and infestations       
Sepsis, Bacteraemia, Viraemia and Fungaemia NEC  1  0/317 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Nervous system disorders       
Central Nervous System Haemorrhage & Cerebrovascular Accidents  1  0/317 (0.00%)  1/315 (0.32%)  0/315 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo QD Dexlansoprazole MR 30 mg QD Dexlansoprazole MR 60 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   34   41   36 
Gastrointestinal disorders       
Diarrhoea (Excluding Infective)  1  11/317 (3.47%)  18/315 (5.71%)  15/315 (4.76%) 
Nausea and Vomiting Symptoms  1  9/317 (2.84%)  16/315 (5.08%)  18/315 (5.71%) 
Nervous system disorders       
Headaches NEC  1  19/317 (5.99%)  13/315 (4.13%)  9/315 (2.86%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
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. 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 Sciences
Organization: Takeda Global Research & Development Center, Inc.
Phone: 800-778-2860
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 )
First Submitted: May 2, 2006
First Posted: May 4, 2006
Results First Submitted: February 26, 2009
Results First Posted: March 23, 2009
Last Update Posted: April 28, 2011