Atrial Fibrillation
Conditions
Brief summary
This is a prospective and open label study that aims to enroll approximately 1200 patients with non-valvular atrial fibrillation (NVAF) not previously treated with Pradaxa® and free of gastrointestinal symptoms (GIS) for at least 2 weeks prior to enrolment. Approximately 125 sites in North America will be recruited. Patients who report GIS during the 3 month treatment period will be randomized to one of two management strategies, and data documenting the intensity and duration of the GIS will be collected.
Interventions
DRUGpantoprazole
40 mg q.a.m, p.o.
150 mg or 75 mg b.i.d. (150 mg or 110 mg b.i.d. in Canada)
DRUGPradaxa, within 30 minutes after a meal
Patients randomized to this intervention would be instructed to take their dabigatran 30 minutes after a meal
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Documented non-valvular atrial fibrillation (NVAF) for whom Pradaxa® (dabigatran etexilate) is indicated per the current local label, but who have not received treatment with Pradaxa® (dabigatran etexilate), or who have not been started on Pradaxa® (dabigatran etexilate) more than 7 days prior to potential enrolment in the study. NVAF may be documented by 12-lead electrocardiogram, rhythm strip, pacemaker/ implantable cardioverter defibrillator (ICD) electrograms or Holter monitoring 2. Male and female patients, age greater than or equal to 18 years at entry 3. Written, informed consent
Exclusion criteria
1. History within 2 weeks of any of the following gastrointestinal (GI) disorders: heartburn, indigestion, gastritis, upper abdominal pain or discomfort, or gastroesophageal reflux requiring the use of proton pump inhibitors, histamine-2 receptor blockers or antacids. Patients with nausea and/or vomiting within the 2 weeks are not excluded if the symptoms were clearly associated with a self-limited acute or febrile illness. Short-term use of PPIs, as prophylaxis, in a hospital setting for the prevention of stress ulcers is acceptable. Calcium carbonate supplements for calcium replacement is not exclusionary (as long as these products are being used as calcium supplementation/replacement and are not being used to treat or relieve GIS.) 2. GI bleeding within one year or any history of symptomatic or endoscopically documented gastroduodenal ulcer or diverticulitis, unless the cause has been permanently eliminated by medical therapy or by surgery(e.g., patients with peptic ulcer disease with endoscopically proven cure after therapy or lower GI bleeding due to diverticulosis cured by segmental colectomy are not excluded.) 3. not applicable 4. Contraindication to pantoprazole or other proton pump inhibitors, e.g. omeprazole, lansoprazole, rabeprazole, atnoprazole, esomeprazole 5. Contraindication to Pradaxa® (dabigatran etexilate) or known hypersensitivity to Pradaxa® (dabigatran etexilate) or its excipients 6. Hemorrhagic disorder, bleeding diathesis or active pathological bleeding 7. Need for anticoagulant treatment for disorders other than atrial fibrillation 8. Current treatment with rifampin 9. Creatinine clearance \<15ml/min (in Canada, \<30ml/min), or patients on renal replacement therapy (dialysis) 10. Pre-menopausal women (last menstruation less than or equal to 1 year prior to informed consent) who: are nursing or pregnant, or are of child bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study. Acceptable methods of birth control include abstinence, tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral implantable or injectable contraceptives, double barrier method and vasectomized partner. 11. Patients who have received an investigational drug in the past 30 days or are participating in another drug study 12. Patients considered unreliable by the investigator concerning the requirements for follow-up during the study 13. Any condition the investigator believes would not allow safe participation in the study 14. Contraindication in patients with mechanical heart valves. The use of Pradaxa in the setting of other forms of valvular heart disease, including the presence of a bio-prosthetic valve, is not recommended.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Rate of Complete Effectiveness of Initial GIS Management Strategy | Week 4 | The percentage of patients experiencing complete relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks. Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies | Week 4 | The percentage of patients experiencing complete or partial effectiveness of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks. Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un-resolved secondary GIS. |
| Rate of Complete Effectiveness of Combined GIS Management Strategies | Week 8 | The percentage of patients experiencing complete relief of combined gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal. Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved. |
| Rate of Partial Effectiveness of Combined GIS Management Strategies | Week 8 | The percentage of patients experiencing partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un-resolved secondary GIS. |
| Combined Rate of Complete or Partial Effectiveness of Combined GIS Management Strategies | Week 8 | The percentage of patients experiencing combined of complete or partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal. Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un-resolved secondary GIS. |
| Rate of Partial Effectiveness of Initial GIS Management Strategies | Week 4 | The percentage of patients experiencing partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) and patients taking Pradaxa® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un-resolved secondary GIS. |
| Rates of Partial Effectiveness of GIS at Each Visit. | Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8 | The percentage of patients experiencing partial effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy. Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy. |
| Rates of Complete or Partial Effectiveness of GIS at Each Visit. | Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8 | The percentage of patients experiencing complete or partial effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy. Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy. |
| Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom | Week 8 | Time between symptom onset and first observed complete or partial effectiveness and between symptom onset and last observed symptom by management strategy. |
| Rates of Complete Effectiveness of GIS at Each Visit. | Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8 | The percentage of patients experiencing complete effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy. Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy. |
Countries
Canada, United States
Participant flow
Pre-assignment details
This is a Prospective, randomized, open label trial. 1067 patients treated with Pradaxa and 117 patients were randomized to a management strategy. NVAF= non-valvular atrial fibrillation and GIS = gastrointestinal symptoms.
Participants by arm
| Arm | Count |
|---|---|
| Pradaxa, 30 Minutes After a Meal (Randomized) Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks). | 59 |
| Pantoprazole 40 mg (Randomized) Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks). | 58 |
| Pradaxa, Never Randomized Patients who were treated for 3 months with Pradaxa ® and were never randomized to management strategies. | 950 |
| Total | 1,067 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Adding the Second Strategy | Other adverse event | 1 | 2 | 0 |
| Adding the Second Strategy | Withdrawal by Subject | 0 | 1 | 0 |
| Adding the Second Strategy | Worsening of events associate with GIS | 1 | 1 | 0 |
| Not Randomized to Management Strategies | Early termination | 0 | 0 | 34 |
| Not Randomized to Management Strategies | Lost to Follow-up | 0 | 0 | 4 |
| Not Randomized to Management Strategies | Other adverse event | 0 | 0 | 54 |
| Not Randomized to Management Strategies | Other than stated above | 0 | 0 | 21 |
| Not Randomized to Management Strategies | Protocol Violation | 0 | 0 | 1 |
| Not Randomized to Management Strategies | Withdrawal by Subject | 0 | 0 | 10 |
| Not Randomized to Management Strategies | Worsening of events associate with NVAF. | 0 | 0 | 1 |
| Not Randomized to Management Strategies | Worsening of other pre-existing disease | 0 | 0 | 9 |
| Randomized to Management Strategies | Other adverse event | 8 | 5 | 0 |
| Randomized to Management Strategies | Other than stated above | 1 | 3 | 0 |
| Randomized to Management Strategies | Protocol Violation | 3 | 0 | 0 |
| Randomized to Management Strategies | Withdrawal by Subject | 0 | 1 | 0 |
| Randomized to Management Strategies | Worsening of events associate with GIS | 3 | 2 | 0 |
Baseline characteristics
| Characteristic | Pradaxa, 30 Minutes After a Meal (Randomized) | Pantoprazole 40 mg (Randomized) | Pradaxa, Never Randomized | Total |
|---|---|---|---|---|
| Age, Continuous | 69.1 Years STANDARD_DEVIATION 11.1 | 69.6 Years STANDARD_DEVIATION 10.8 | 69.7 Years STANDARD_DEVIATION 10.7 | 69.7 Years STANDARD_DEVIATION 10.7 |
| Sex: Female, Male Female | 22 Participants | 20 Participants | 304 Participants | 346 Participants |
| Sex: Female, Male Male | 37 Participants | 38 Participants | 646 Participants | 721 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 37 / 59 | 35 / 58 | 161 / 950 |
| serious Total, serious adverse events | 2 / 59 | 3 / 58 | 109 / 950 |
Outcome results
Primary
The Rate of Complete Effectiveness of Initial GIS Management Strategy
The percentage of patients experiencing complete relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks. Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved.
Time frame: Week 4
Population: Full Analysis Set (FAS): This patient set included all patients who developed GIS and who were randomized into the two management strategies.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pradaxa, 30 Minutes After a Meal (Randomized) | The Rate of Complete Effectiveness of Initial GIS Management Strategy | 55.9 percentage of participants |
| Pantoprazole 40 mg (Randomized) | The Rate of Complete Effectiveness of Initial GIS Management Strategy | 67.2 percentage of participants |
Comparison: Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.p-value: 0.255495% CI: [-6.54, 29.49]Fisher Exact
Secondary
Combined Rate of Complete or Partial Effectiveness of Combined GIS Management Strategies
The percentage of patients experiencing combined of complete or partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal. Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un-resolved secondary GIS.
Time frame: Week 8
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pradaxa, 30 Minutes After a Meal (Randomized) | Combined Rate of Complete or Partial Effectiveness of Combined GIS Management Strategies | 85.7 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Combined Rate of Complete or Partial Effectiveness of Combined GIS Management Strategies | 80.0 percentage of participants |
Comparison: Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.p-value: 195% CI: [-41.25, 28.77]Fisher Exact
Secondary
Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies
The percentage of patients experiencing complete or partial effectiveness of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks. Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un-resolved secondary GIS.
Time frame: Week 4
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pradaxa, 30 Minutes After a Meal (Randomized) | Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies | 67.8 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies | 86.2 percentage of participants |
Comparison: Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.p-value: 0.027395% CI: [0.71, 35.98]Fisher Exact
Secondary
Rate of Complete Effectiveness of Combined GIS Management Strategies
The percentage of patients experiencing complete relief of combined gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal. Complete effectiveness is defined as at the time of evaluation, both primary GIS and secondary GIS are all resolved.
Time frame: Week 8
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rate of Complete Effectiveness of Combined GIS Management Strategies | 42.9 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rate of Complete Effectiveness of Combined GIS Management Strategies | 33.3 percentage of participants |
Comparison: Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.p-value: 0.710495% CI: [-44.22, 28.4]Fisher Exact
Secondary
Rate of Partial Effectiveness of Combined GIS Management Strategies
The percentage of patients experiencing partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) vs. administration of Pradaxa ® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un-resolved secondary GIS.
Time frame: Week 8
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rate of Partial Effectiveness of Combined GIS Management Strategies | 42.9 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rate of Partial Effectiveness of Combined GIS Management Strategies | 46.7 percentage of participants |
Comparison: Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.p-value: 195% CI: [-32.94, 40.44]Fisher Exact
Secondary
Rate of Partial Effectiveness of Initial GIS Management Strategies
The percentage of patients experiencing partial relief of gastrointestinal symptoms (GIS) when taking pantoprazole 40 mg once daily in the morning (q.a.m.) and patients taking Pradaxa® (dabigatran etexilate) within 30 minutes after a meal at 4 weeks. Partial effectiveness is defined as at the time of evaluation, either primary GIS is improved; or primary GIS is resolved, but there were still un-resolved secondary GIS.
Time frame: Week 4
Population: Full Analysis Set (FAS)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rate of Partial Effectiveness of Initial GIS Management Strategies | 11.9 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rate of Partial Effectiveness of Initial GIS Management Strategies | 19.0 percentage of participants |
Comparison: Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.p-value: 0.316595% CI: [-11.24, 24.58]Fisher Exact
Secondary
Rates of Complete Effectiveness of GIS at Each Visit.
The percentage of patients experiencing complete effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy. Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.
Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8
Population: Full analysis Set (FAS).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Complete Effectiveness of GIS at Each Visit. | GIS 3 (Week 1, n= 59 , 58) | 39.0 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Complete Effectiveness of GIS at Each Visit. | GIS 7 (Week 5, n= 14 , 15) | 28.6 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Complete Effectiveness of GIS at Each Visit. | GIS 5 (Week 3, n= 59 , 58) | 55.9 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Complete Effectiveness of GIS at Each Visit. | GIS 8 (Week 6, n= 14 , 15) | 42.9 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Complete Effectiveness of GIS at Each Visit. | GIS 4 (Week 2, n= 59 , 58) | 45.8 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Complete Effectiveness of GIS at Each Visit. | GIS 9 (Week 7, n= 14 , 15) | 42.9 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Complete Effectiveness of GIS at Each Visit. | GIS 6 (Week 4, n= 59 , 58) | 55.9 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Complete Effectiveness of GIS at Each Visit. | GIS 10 (Week 8, n= 14 , 15) | 42.9 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Complete Effectiveness of GIS at Each Visit. | Baseline (n= 59 , 58) | 0.0 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Complete Effectiveness of GIS at Each Visit. | GIS 10 (Week 8, n= 14 , 15) | 33.3 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Complete Effectiveness of GIS at Each Visit. | Baseline (n= 59 , 58) | 0.0 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Complete Effectiveness of GIS at Each Visit. | GIS 3 (Week 1, n= 59 , 58) | 51.7 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Complete Effectiveness of GIS at Each Visit. | GIS 4 (Week 2, n= 59 , 58) | 55.2 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Complete Effectiveness of GIS at Each Visit. | GIS 5 (Week 3, n= 59 , 58) | 60.3 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Complete Effectiveness of GIS at Each Visit. | GIS 6 (Week 4, n= 59 , 58) | 67.2 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Complete Effectiveness of GIS at Each Visit. | GIS 7 (Week 5, n= 14 , 15) | 40.0 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Complete Effectiveness of GIS at Each Visit. | GIS 8 (Week 6, n= 14 , 15) | 40.0 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Complete Effectiveness of GIS at Each Visit. | GIS 9 (Week 7, n= 14 , 15) | 33.3 percentage of participants |
Secondary
Rates of Complete or Partial Effectiveness of GIS at Each Visit.
The percentage of patients experiencing complete or partial effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy. Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.
Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8
Population: Full Analysis Set (FAS).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Complete or Partial Effectiveness of GIS at Each Visit. | GIS 3 (Week 1, n= 59 , 58) | 55.9 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Complete or Partial Effectiveness of GIS at Each Visit. | GIS 7 (Week 5, n= 14 , 15) | 50.0 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Complete or Partial Effectiveness of GIS at Each Visit. | GIS 5 (Week 3, n= 59 , 58) | 64.4 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Complete or Partial Effectiveness of GIS at Each Visit. | GIS 8 (Week 6, n= 14 , 15) | 85.7 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Complete or Partial Effectiveness of GIS at Each Visit. | GIS 4 (Week 2, n= 59 , 58) | 59.3 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Complete or Partial Effectiveness of GIS at Each Visit. | GIS 9 (Week 7, n= 14 , 15) | 85.7 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Complete or Partial Effectiveness of GIS at Each Visit. | GIS 6 (Week 4, n= 59 , 58) | 67.8 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Complete or Partial Effectiveness of GIS at Each Visit. | GIS 10 (Week 8, n= 14 , 15) | 85.7 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Complete or Partial Effectiveness of GIS at Each Visit. | Baseline (n= 59 , 58) | 0.0 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Complete or Partial Effectiveness of GIS at Each Visit. | GIS 10 (Week 8, n= 14 , 15) | 80.0 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Complete or Partial Effectiveness of GIS at Each Visit. | Baseline (n= 59 , 58) | 0.0 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Complete or Partial Effectiveness of GIS at Each Visit. | GIS 3 (Week 1, n= 59 , 58) | 65.5 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Complete or Partial Effectiveness of GIS at Each Visit. | GIS 4 (Week 2, n= 59 , 58) | 79.3 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Complete or Partial Effectiveness of GIS at Each Visit. | GIS 5 (Week 3, n= 59 , 58) | 82.8 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Complete or Partial Effectiveness of GIS at Each Visit. | GIS 6 (Week 4, n= 59 , 58) | 86.2 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Complete or Partial Effectiveness of GIS at Each Visit. | GIS 7 (Week 5, n= 14 , 15) | 80.0 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Complete or Partial Effectiveness of GIS at Each Visit. | GIS 8 (Week 6, n= 14 , 15) | 80.0 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Complete or Partial Effectiveness of GIS at Each Visit. | GIS 9 (Week 7, n= 14 , 15) | 80.0 percentage of participants |
Secondary
Rates of Partial Effectiveness of GIS at Each Visit.
The percentage of patients experiencing partial effectiveness of gastrointestinal symptoms (GIS) at each visit by management strategy. Evaluation of GIS was based on Last observation carried forward (LOCF) data up to the last observed time or up to adding the second management strategy.
Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Partial Effectiveness of GIS at Each Visit. | GIS 4 (Week 2, n= 59 , 58) | 13.6 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Partial Effectiveness of GIS at Each Visit. | GIS 8 (Week 6, n= 14 , 15) | 42.9 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Partial Effectiveness of GIS at Each Visit. | GIS 6 (Week 4, n= 59 , 58) | 11.9 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Partial Effectiveness of GIS at Each Visit. | GIS 9 (Week 7, n= 14 , 15) | 42.9 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Partial Effectiveness of GIS at Each Visit. | GIS 5 (Week 3, n= 59 , 58) | 8.5 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Partial Effectiveness of GIS at Each Visit. | GIS 10 (Week 8, n= 14 , 15) | 42.9 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Partial Effectiveness of GIS at Each Visit. | GIS 7 (Week 5, n= 14 , 15) | 21.4 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Partial Effectiveness of GIS at Each Visit. | Baseline (n= 59 , 58) | 0.0 percentage of participants |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Rates of Partial Effectiveness of GIS at Each Visit. | GIS 3 (Week 1, n= 59 , 58) | 16.9 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Partial Effectiveness of GIS at Each Visit. | Baseline (n= 59 , 58) | 0.0 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Partial Effectiveness of GIS at Each Visit. | GIS 3 (Week 1, n= 59 , 58) | 13.8 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Partial Effectiveness of GIS at Each Visit. | GIS 4 (Week 2, n= 59 , 58) | 24.1 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Partial Effectiveness of GIS at Each Visit. | GIS 5 (Week 3, n= 59 , 58) | 22.4 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Partial Effectiveness of GIS at Each Visit. | GIS 6 (Week 4, n= 59 , 58) | 19.0 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Partial Effectiveness of GIS at Each Visit. | GIS 7 (Week 5, n= 14 , 15) | 40.0 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Partial Effectiveness of GIS at Each Visit. | GIS 8 (Week 6, n= 14 , 15) | 40.0 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Partial Effectiveness of GIS at Each Visit. | GIS 9 (Week 7, n= 14 , 15) | 46.7 percentage of participants |
| Pantoprazole 40 mg (Randomized) | Rates of Partial Effectiveness of GIS at Each Visit. | GIS 10 (Week 8, n= 14 , 15) | 46.7 percentage of participants |
Secondary
Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom
Time between symptom onset and first observed complete or partial effectiveness and between symptom onset and last observed symptom by management strategy.
Time frame: Week 8
Population: Full Analysis Set (FAS)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pradaxa, 30 Minutes After a Meal (Randomized) | Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom | Duration of GIS (N= 58; 58) | 23.5 days | Standard Deviation 25.67 |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom | Time to first complete effectiveness (N= 43; 50) | 12.1 days | Standard Deviation 13.45 |
| Pradaxa, 30 Minutes After a Meal (Randomized) | Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom | Time to first partial effectiveness(N= 6; 2) | 23.7 days | Standard Deviation 15.5 |
| Pantoprazole 40 mg (Randomized) | Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom | Duration of GIS (N= 58; 58) | 23.9 days | Standard Deviation 25.35 |
| Pantoprazole 40 mg (Randomized) | Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom | Time to first complete effectiveness (N= 43; 50) | 10.7 days | Standard Deviation 10.23 |
| Pantoprazole 40 mg (Randomized) | Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom | Time to first partial effectiveness(N= 6; 2) | 3.5 days | Standard Deviation 2.12 |
Comparison: Mean difference for the Duration of gastrointestinal symptoms (GIS).95% CI: [-9.9, 8.9]
Comparison: Mean difference for Time to first complete effectiveness. Complete effectiveness of a gastrointestinal symptoms (GIS) management strategy can only be measured at a point in time. Because the same or a different GIS could occur after a time of effective GIS management, the patients who indicated some degree of effectiveness at one visit may not be the same patients who experience effectiveness at a subsequent visit.95% CI: [-3.5, 6.3]
Comparison: Mean difference for Time to first complete effectiveness. Partial effectiveness of a gastrointestinal symptoms (GIS) management strategy can only be measured at a point in time. Because the same or a different GIS could occur after a time of effective GIS management, the patients who indicated some degree of effectiveness at one visit may not be the same patients who experience effectiveness at a subsequent visit.95% CI: [-8.2, 48.5]