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

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ClinicalTrials.gov Identifier: NCT00847808
Recruitment Status : Completed
First Posted : February 19, 2009
Results First Posted : April 29, 2011
Last Update Posted : February 3, 2012
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Gastroesophageal Reflux
Intervention Drug: Dexlansoprazole MR QD
Enrollment 178
Recruitment Details Participants enrolled at 45 investigative sites in the United States from 10 February 2009 to 15 April 2010.
Pre-assignment Details 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.
Arm/Group Title Dexlansoprazole MR QD
Hide Arm/Group Description Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
Period Title: Overall Study
Started 178
Completed 163
Not Completed 15
Reason Not Completed
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
Arm/Group Title Dexlansoprazole MR QD
Hide Arm/Group Description Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
Overall Number of Baseline Participants 178
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 178 participants
<45 years 56
45 to <65 years 94
≥65 years 28
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 178 participants
Female
107
  60.1%
Male
71
  39.9%
1.Primary Outcome
Title Proportion of Participants Who Remain Well Controlled After Switching From Their Current Twice-daily Proton Pump Inhibitor Therapy to Dexlansoprazole MR.
Hide Description Well-controlled participants were defined to be participants who completed the study having at least 23 days of evaluable diary entries between Days 15 and 42, inclusive, and had ≤4 occurrences of heartburn during this period.
Time Frame Week 3 through Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Dexlansoprazole MR QD
Hide Arm/Group Description:
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
Overall Number of Participants Analyzed 142
Measure Type: Number
Unit of Measure: percent of participants
88
2.Secondary Outcome
Title 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.
Hide Description PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Dexlansoprazole MR QD
Hide Arm/Group Description:
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.05  (0.467)
3.Secondary Outcome
Title Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Clothing Subscale in Participants Who Remain Well-controlled.
Hide Description PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Dexlansoprazole MR QD
Hide Arm/Group Description:
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.02  (0.717)
4.Secondary Outcome
Title 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.
Hide Description PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Dexlansoprazole MR QD
Hide Arm/Group Description:
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.27  (0.858)
5.Secondary Outcome
Title Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Relationship Subscale in Participants Who Remain Well-controlled.
Hide Description PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Dexlansoprazole MR QD
Hide Arm/Group Description:
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.10  (0.415)
6.Secondary Outcome
Title 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.
Hide Description PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Dexlansoprazole MR QD
Hide Arm/Group Description:
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.03  (0.541)
7.Secondary Outcome
Title Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Total Score in Participants Who Remain Well-controlled.
Hide Description PAGI-QOL is a 30-item self-reported instrument assessing health-related quality of life impact of upper gastrointestinal disorders. It includes 30 items across five subscales (daily activities, clothing, diet/food habits, relationship, psychological well-being and distress), scored on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (all the time). For reporting purposes, the scores are reversed and higher scores reflect improved quality of life and positive changes from baseline indicate improved quality of life.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Dexlansoprazole MR QD
Hide Arm/Group Description:
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.09  (0.417)
8.Secondary Outcome
Title Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Nausea/Vomiting Subscale in Participants Who Remain Well-controlled.
Hide Description PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Dexlansoprazole MR QD
Hide Arm/Group Description:
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.00  (0.522)
9.Secondary Outcome
Title 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.
Hide Description PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Dexlansoprazole MR QD
Hide Arm/Group Description:
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.10  (0.730)
10.Secondary Outcome
Title Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Bloating Subscale in Participants Who Remain Well-controlled.
Hide Description PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Dexlansoprazole MR QD
Hide Arm/Group Description:
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.20  (1.024)
11.Secondary Outcome
Title 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.
Hide Description PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Dexlansoprazole MR QD
Hide Arm/Group Description:
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.08  (0.981)
12.Secondary Outcome
Title 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.
Hide Description PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Dexlansoprazole MR QD
Hide Arm/Group Description:
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.03  (0.628)
13.Secondary Outcome
Title Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Heartburn/Regurgitation Subscale in Participants Who Remain Well-controlled.
Hide Description PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Dexlansoprazole MR QD
Hide Arm/Group Description:
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.14  (0.729)
14.Secondary Outcome
Title Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Total Score in Participants Who Remain Well-controlled.
Hide Description PAGI-SYM is a 20-item self-reported questionnaire that measures symptom severity of upper gastrointestinal disorders across six subscales (nausea/vomiting, fullness/early satiety, bloating, upper abdominal pain, lower abdominal pain, heartburn/regurgitation) which are summarized by individual subscale scores and a total score. The items are rated on a 6-point Likert scale with subscale and total score ranging from 0 (none) to 5 (very severe). Higher scores indicate higher symptom severity and thus negative changes from baseline indicate decrease in symptom severity.
Time Frame Baseline and Week 6.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values are from the Full Analysis Set.
Arm/Group Title Dexlansoprazole MR QD
Hide Arm/Group Description:
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
Overall Number of Participants Analyzed 120
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.09  (0.563)
Time Frame Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of single-blind study drug.
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Dexlansoprazole MR QD
Hide Arm/Group Description Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
All-Cause Mortality
Dexlansoprazole MR QD
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dexlansoprazole MR QD
Affected / at Risk (%)
Total   6/178 (3.37%) 
Gastrointestinal disorders   
Diverticular perforation  1  1/178 (0.56%) 
Infections and infestations   
Cellulitis  1  1/178 (0.56%) 
Injury, poisoning and procedural complications   
Animal bite  1  1/178 (0.56%) 
Intentional overdose  1  1/178 (0.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer female  1  1/178 (0.56%) 
Nervous system disorders   
Dizziness  1  1/178 (0.56%) 
Psychiatric disorders   
Suicidal behaviour  1  1/178 (0.56%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/178 (0.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Dexlansoprazole MR QD
Affected / at Risk (%)
Total   34/178 (19.10%) 
Gastrointestinal disorders   
Abdominal pain upper  1  4/178 (2.25%) 
Diarrhoea  1  7/178 (3.93%) 
Flatulence  1  5/178 (2.81%) 
Infections and infestations   
Nasopharyngitis  1  4/178 (2.25%) 
Upper respiratory tract infection  1  5/178 (2.81%) 
Nervous system disorders   
Headache  1  7/178 (3.93%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  6/178 (3.37%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
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 first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay 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: Takeda
ClinicalTrials.gov Identifier: NCT00847808     History of Changes
Other Study ID Numbers: T-GD08-178
U1111-1112-1761 ( Registry Identifier: WHO )
First Submitted: February 18, 2009
First Posted: February 19, 2009
Results First Submitted: April 5, 2011
Results First Posted: April 29, 2011
Last Update Posted: February 3, 2012