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Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00251758
Recruitment Status : Completed
First Posted : November 10, 2005
Results First Posted : March 23, 2009
Last Update Posted : May 18, 2010
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 908
Recruitment Details 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 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 60 mg QD Dexlansoprazole MR 90 mg QD
Hide Arm/Group Description Placebo capsules, orally, once daily for up to 4 weeks. Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks. Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
Period Title: Overall Study
Started 292 312 304
Completed 264 285 277
Not Completed 28 27 27
Reason Not Completed
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
Arm/Group Title Placebo QD Dexlansoprazole MR 60 mg QD Dexlansoprazole MR 90 mg QD Total
Hide Arm/Group Description Placebo capsules, orally, once daily for up to 4 weeks. Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks. Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks. Total of all reporting groups
Overall Number of Baseline Participants 292 312 304 908
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 292 participants 312 participants 304 participants 908 participants
49.0  (13.60) 48.0  (13.55) 46.7  (13.64) 47.9  (13.61)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 292 participants 312 participants 304 participants 908 participants
<45 years 107 125 135 367
45 - <65 years 146 155 139 440
≥65 years 39 32 30 101
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 292 participants 312 participants 304 participants 908 participants
Female
216
  74.0%
214
  68.6%
213
  70.1%
643
  70.8%
Male
76
  26.0%
98
  31.4%
91
  29.9%
265
  29.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 292 participants 312 participants 304 participants 908 participants
American Indian or Alaska Native
3
   1.0%
3
   1.0%
8
   2.6%
14
   1.5%
Asian
9
   3.1%
12
   3.8%
7
   2.3%
28
   3.1%
Native Hawaiian or Other Pacific Islander
1
   0.3%
3
   1.0%
0
   0.0%
4
   0.4%
Black or African American
34
  11.6%
46
  14.7%
41
  13.5%
121
  13.3%
White
240
  82.2%
246
  78.8%
245
  80.6%
731
  80.5%
More than one race
5
   1.7%
1
   0.3%
3
   1.0%
9
   1.0%
Unknown or Not Reported
0
   0.0%
1
   0.3%
0
   0.0%
1
   0.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 292 participants 312 participants 304 participants 908 participants
Hispanic or Latino
60
  20.5%
58
  18.6%
61
  20.1%
179
  19.7%
Not Hispanic or Latino
232
  79.5%
254
  81.4%
243
  79.9%
729
  80.3%
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
Hide 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 60 mg QD Dexlansoprazole MR 90 mg QD
Hide Arm/Group Description:
Placebo capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
Overall Number of Participants Analyzed 290 306 298
Median (Inter-Quartile Range)
Unit of Measure: percentage of days
17.0
(0.0 to 42.9)
45.7
(11.1 to 75.0)
52.7
(15.8 to 79.2)
Hide Statistical Analysis 1
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]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Dexlansoprazole MR 90 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]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Dexlansoprazole MR 60 mg QD, Dexlansoprazole MR 90 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 0.15505
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
Hide 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 60 mg QD Dexlansoprazole MR 90 mg QD
Hide Arm/Group Description:
Placebo capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
Overall Number of Participants Analyzed 290 306 298
Mean (Standard Deviation)
Unit of Measure: percentage of days
24.9  (25.7) 44.8  (33.8) 49.1  (34.2)
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
Hide 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 60 mg QD Dexlansoprazole MR 90 mg QD
Hide Arm/Group Description:
Placebo capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
Overall Number of Participants Analyzed 290 306 298
Median (Inter-Quartile Range)
Unit of Measure: percentage of days
51.0
(18.5 to 81.3)
72.3
(34.6 to 92.9)
76.6
(37.0 to 92.6)
Hide Statistical Analysis 1
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]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo QD, Dexlansoprazole MR 90 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]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Dexlansoprazole MR 60 mg QD, Dexlansoprazole MR 90 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 0.38740
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
Hide 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 60 mg QD Dexlansoprazole MR 90 mg QD
Hide Arm/Group Description:
Placebo capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
Overall Number of Participants Analyzed 290 306 298
Mean (Standard Deviation)
Unit of Measure: percentage of days
49.6  (34.1) 62.0  (34.5) 64.4  (34.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo QD Dexlansoprazole MR 60 mg QD Dexlansoprazole MR 90 mg QD
Hide Arm/Group Description Placebo capsules, orally, once daily for up to 4 weeks. Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks. Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
All-Cause Mortality
Placebo QD Dexlansoprazole MR 60 mg QD Dexlansoprazole MR 90 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Placebo QD Dexlansoprazole MR 60 mg QD Dexlansoprazole MR 90 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0   2   1 
Hepatobiliary disorders       
Cholecystitis and Cholelithiasis  1  0/292 (0.00%)  0/312 (0.00%)  1/304 (0.33%) 
Injury, poisoning and procedural complications       
Non-site Specific Injuries Not Elsewhere Classified (NEC)  1  0/292 (0.00%)  1/312 (0.32%)  0/304 (0.00%) 
Poisoning and Toxicity  1  0/292 (0.00%)  1/312 (0.32%)  0/304 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo QD Dexlansoprazole MR 60 mg QD Dexlansoprazole MR 90 mg QD
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   37   55   54 
Gastrointestinal disorders       
Diarrhoea (Excl Infective)  1  13/292 (4.45%)  15/312 (4.81%)  8/304 (2.63%) 
Gastrointestinal and Abdominal Pains (Excl Oral and Throat)  1  12/292 (4.11%)  23/312 (7.37%)  15/304 (4.93%) 
Nausea and Vomiting Symptoms  1  10/292 (3.42%)  15/312 (4.81%)  9/304 (2.96%) 
Infections and infestations       
Upper Respiratory Tract Infections  1  4/292 (1.37%)  11/312 (3.53%)  24/304 (7.89%) 
Nervous system disorders       
Headaches NEC  1  15/292 (5.14%)  13/312 (4.17%)  11/304 (3.62%) 
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
Layout table for Results Point of Contact information
Name/Title: Sr. VP Clinical Sciences
Organization: Takeda Global Research & Development Center, Inc.
Phone: 800-778-2860
EMail: clinicaltrialregistry@tpna.com
Layout table for additonal information
Responsible Party: Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00251758    
Other Study ID Numbers: T-GD04-083
U1111-1114-1811 ( Registry Identifier: WHO )
First Submitted: November 8, 2005
First Posted: November 10, 2005
Results First Submitted: February 26, 2009
Results First Posted: March 23, 2009
Last Update Posted: May 18, 2010