Trial Outcomes & Findings for Efficacy of Dexlansoprazole MR on Heartburn Control in Participants Previously Receiving Twice Daily Proton Pump Inhibitor Therapy (NCT NCT00847808)
NCT ID: NCT00847808
Last Updated: 2012-02-03
Results Overview
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.
COMPLETED
PHASE3
178 participants
Week 3 through Week 6
2012-02-03
Participant Flow
Participants enrolled at 45 investigative sites in the United States from 10 February 2009 to 15 April 2010.
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.
Participant milestones
| Measure |
Dexlansoprazole MR QD
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
|
|---|---|
|
Overall Study
STARTED
|
178
|
|
Overall Study
COMPLETED
|
163
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Dexlansoprazole MR QD
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Participant Reported Lack of Efficacy
|
1
|
|
Overall Study
Participant Took Excluded Medication
|
1
|
Baseline Characteristics
Efficacy of Dexlansoprazole MR on Heartburn Control in Participants Previously Receiving Twice Daily Proton Pump Inhibitor Therapy
Baseline characteristics by cohort
| Measure |
Dexlansoprazole MR QD
n=178 Participants
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
|
|---|---|
|
Age, Customized
<45 years
|
56 participants
n=5 Participants
|
|
Age, Customized
45 to <65 years
|
94 participants
n=5 Participants
|
|
Age, Customized
≥65 years
|
28 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 3 through Week 6Population: Values are from the Full Analysis Set.
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.
Outcome measures
| Measure |
Dexlansoprazole MR QD
n=142 Participants
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
|
|---|---|
|
Proportion of Participants Who Remain Well Controlled After Switching From Their Current Twice-daily Proton Pump Inhibitor Therapy to Dexlansoprazole MR.
|
88 percent of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Values are from the Full Analysis Set.
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.
Outcome measures
| Measure |
Dexlansoprazole MR QD
n=120 Participants
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
|
|---|---|
|
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.
|
0.05 units on a scale
Standard Deviation 0.467
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Values are from the Full Analysis Set.
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.
Outcome measures
| Measure |
Dexlansoprazole MR QD
n=120 Participants
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
|
|---|---|
|
Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Clothing Subscale in Participants Who Remain Well-controlled.
|
0.02 units on a scale
Standard Deviation 0.717
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Values are from the Full Analysis Set.
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.
Outcome measures
| Measure |
Dexlansoprazole MR QD
n=120 Participants
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
|
|---|---|
|
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.
|
0.27 units on a scale
Standard Deviation 0.858
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Values are from the Full Analysis Set.
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.
Outcome measures
| Measure |
Dexlansoprazole MR QD
n=120 Participants
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
|
|---|---|
|
Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Relationship Subscale in Participants Who Remain Well-controlled.
|
0.10 units on a scale
Standard Deviation 0.415
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Values are from the Full Analysis Set.
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.
Outcome measures
| Measure |
Dexlansoprazole MR QD
n=120 Participants
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
|
|---|---|
|
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.
|
0.03 units on a scale
Standard Deviation 0.541
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Values are from the Full Analysis Set.
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.
Outcome measures
| Measure |
Dexlansoprazole MR QD
n=120 Participants
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
|
|---|---|
|
Change From Baseline in the Patient Assessment of Upper Gastrointestinal Disorders - Quality of Life (PAGI-QOL) - Total Score in Participants Who Remain Well-controlled.
|
0.09 units on a scale
Standard Deviation 0.417
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Values are from the Full Analysis Set.
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.
Outcome measures
| Measure |
Dexlansoprazole MR QD
n=120 Participants
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
|
|---|---|
|
Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Nausea/Vomiting Subscale in Participants Who Remain Well-controlled.
|
0.00 units on a scale
Standard Deviation 0.522
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Values are from the Full Analysis Set.
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.
Outcome measures
| Measure |
Dexlansoprazole MR QD
n=120 Participants
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
|
|---|---|
|
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.
|
-0.10 units on a scale
Standard Deviation 0.730
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Values are from the Full Analysis Set.
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.
Outcome measures
| Measure |
Dexlansoprazole MR QD
n=120 Participants
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
|
|---|---|
|
Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Bloating Subscale in Participants Who Remain Well-controlled.
|
-0.20 units on a scale
Standard Deviation 1.024
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Values are from the Full Analysis Set.
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.
Outcome measures
| Measure |
Dexlansoprazole MR QD
n=120 Participants
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
|
|---|---|
|
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.
|
-0.08 units on a scale
Standard Deviation 0.981
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Values are from the Full Analysis Set.
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.
Outcome measures
| Measure |
Dexlansoprazole MR QD
n=120 Participants
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
|
|---|---|
|
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.
|
-0.03 units on a scale
Standard Deviation 0.628
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Values are from the Full Analysis Set.
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.
Outcome measures
| Measure |
Dexlansoprazole MR QD
n=120 Participants
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
|
|---|---|
|
Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Heartburn/Regurgitation Subscale in Participants Who Remain Well-controlled.
|
-0.14 units on a scale
Standard Deviation 0.729
|
SECONDARY outcome
Timeframe: Baseline and Week 6.Population: Values are from the Full Analysis Set.
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.
Outcome measures
| Measure |
Dexlansoprazole MR QD
n=120 Participants
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
|
|---|---|
|
Change From Baseline in Patient Assessment of Upper Gastrointestinal Disorders - Symptom Severity Index (PAGI-SYM) - Total Score in Participants Who Remain Well-controlled.
|
-0.09 units on a scale
Standard Deviation 0.563
|
Adverse Events
Dexlansoprazole MR QD
Serious adverse events
| Measure |
Dexlansoprazole MR QD
n=178 participants at risk
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
|
|---|---|
|
Gastrointestinal disorders
Diverticular perforation
|
0.56%
1/178 • 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.
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.
|
|
Infections and infestations
Cellulitis
|
0.56%
1/178 • 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.
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.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.56%
1/178 • 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.
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.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.56%
1/178 • 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.
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.56%
1/178 • 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.
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.
|
|
Nervous system disorders
Dizziness
|
0.56%
1/178 • 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.
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.
|
|
Psychiatric disorders
Suicidal behaviour
|
0.56%
1/178 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.56%
1/178 • 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.
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.
|
Other adverse events
| Measure |
Dexlansoprazole MR QD
n=178 participants at risk
Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.2%
4/178 • 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.
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.9%
7/178 • 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.
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.
|
|
Gastrointestinal disorders
Flatulence
|
2.8%
5/178 • 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.
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.
|
|
Infections and infestations
Nasopharyngitis
|
2.2%
4/178 • 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.
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
5/178 • 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.
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.
|
|
Nervous system disorders
Headache
|
3.9%
7/178 • 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.
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
6/178 • 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.
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.
|
Additional Information
Sr. VP, Clinical Science
Takeda Global Research and Development Center, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER