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A Prospective, Open Label Study Evaluating Two Management Strategies on Gastrointestinal Symptoms in Patients Newly on Treatment With Pradaxa for the Prevention of Stroke and Systemic Embolism With Non-valvular Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT01493557
Recruitment Status : Completed
First Posted : December 16, 2011
Results First Posted : October 5, 2015
Last Update Posted : October 5, 2015
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Atrial Fibrillation
Interventions Drug: pantoprazole
Drug: Pradaxa (dabigatran etexilate)
Drug: Pradaxa, within 30 minutes after a meal
Enrollment 1067
Recruitment Details  
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.
Arm/Group Title Pradaxa, 30 Minutes After a Meal (Randomized) Pantoprazole 40 mg (Randomized) Pradaxa, Never Randomized
Hide Arm/Group Description 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). 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). Patients who were treated for 3 months with Pradaxa ® and were never randomized to management strategies.
Period Title: Not Randomized to Management Strategies
Started 0 0 950
Without Experiencing GIS 0 0 854 [1]
Reported GIS Prior to EOT Visit 0 0 48 [2]
Reported GIS Only at EOT Visit 0 0 48 [3]
Completed 0 0 816
Not Completed 0 0 134
Reason Not Completed
Worsening of events associate with NVAF.             0             0             1
Worsening of other pre−existing disease             0             0             9
Other adverse event             0             0             54
Protocol Violation             0             0             1
Lost to Follow-up             0             0             4
Withdrawal by Subject             0             0             10
Early termination             0             0             34
Other than stated above             0             0             21
[1]
754 patients completed the trial.
[2]
32 patients completed the trial.
[3]
26 patients completed (GIS resolved ) and 4 patients completed (GIS not resolved ) the trial.
Period Title: Randomized to Management Strategies
Started 59 58 0
Completed 44 47 0
Not Completed 15 11 0
Reason Not Completed
Worsening of events associate with GIS             3             2             0
Other adverse event             8             5             0
Protocol Violation             3             0             0
Withdrawal by Subject             0             1             0
Other than stated above             1             3             0
Period Title: Adding the Second Strategy
Started 14 15 0
Completed 12 11 0
Not Completed 2 4 0
Reason Not Completed
Worsening of events associate with GIS             1             1             0
Other adverse event             1             2             0
Withdrawal by Subject             0             1             0
Arm/Group Title Pradaxa, 30 Minutes After a Meal (Randomized) Pantoprazole 40 mg (Randomized) Pradaxa, Never Randomized Total
Hide Arm/Group Description 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). 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). Patients who were treated for 3 months with Pradaxa ® and were never randomized to management strategies. Total of all reporting groups
Overall Number of Baseline Participants 59 58 950 1067
Hide Baseline Analysis Population Description
Entered Set (ES): This patient set included all patients entered in the study. For those patients who were randomized to management strategies, their data prior to randomization was included in the entered set. All data from patients who were never randomized are in the entered set.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 58 participants 950 participants 1067 participants
69.1  (11.1) 69.6  (10.8) 69.7  (10.7) 69.7  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 58 participants 950 participants 1067 participants
Female
22
  37.3%
20
  34.5%
304
  32.0%
346
  32.4%
Male
37
  62.7%
38
  65.5%
646
  68.0%
721
  67.6%
1.Primary Outcome
Title The Rate of Complete Effectiveness of Initial GIS Management Strategy
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): This patient set included all patients who developed GIS and who were randomized into the two management strategies.
Arm/Group Title Pradaxa, 30 Minutes After a Meal (Randomized) Pantoprazole 40 mg (Randomized)
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 59 58
Measure Type: Number
Unit of Measure: percentage of participants
55.9 67.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pradaxa, 30 Minutes After a Meal (Randomized), Pantoprazole 40 mg (Randomized)
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2554
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.31
Confidence Interval (2-Sided) 95%
-6.54 to 29.49
Estimation Comments Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.
2.Secondary Outcome
Title Rate of Partial Effectiveness of Initial GIS Management Strategies
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Pradaxa, 30 Minutes After a Meal (Randomized) Pantoprazole 40 mg (Randomized)
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 59 58
Measure Type: Number
Unit of Measure: percentage of participants
11.9 19.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pradaxa, 30 Minutes After a Meal (Randomized), Pantoprazole 40 mg (Randomized)
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3165
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.10
Confidence Interval (2-Sided) 95%
-11.24 to 24.58
Estimation Comments Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.
3.Secondary Outcome
Title Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Pradaxa, 30 Minutes After a Meal (Randomized) Pantoprazole 40 mg (Randomized)
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 59 58
Measure Type: Number
Unit of Measure: percentage of participants
67.8 86.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pradaxa, 30 Minutes After a Meal (Randomized), Pantoprazole 40 mg (Randomized)
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0273
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 18.41
Confidence Interval (2-Sided) 95%
0.71 to 35.98
Estimation Comments Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.
4.Secondary Outcome
Title Rate of Complete Effectiveness of Combined GIS Management Strategies
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Pradaxa, 30 Minutes After a Meal (Randomized) Pantoprazole 40 mg (Randomized)
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 14 15
Measure Type: Number
Unit of Measure: percentage of participants
42.9 33.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pradaxa, 30 Minutes After a Meal (Randomized), Pantoprazole 40 mg (Randomized)
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7104
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.52
Confidence Interval (2-Sided) 95%
-44.22 to 28.40
Estimation Comments Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.
5.Secondary Outcome
Title Rate of Partial Effectiveness of Combined GIS Management Strategies
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Pradaxa, 30 Minutes After a Meal (Randomized) Pantoprazole 40 mg (Randomized)
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 14 15
Measure Type: Number
Unit of Measure: percentage of participants
42.9 46.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pradaxa, 30 Minutes After a Meal (Randomized), Pantoprazole 40 mg (Randomized)
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.81
Confidence Interval (2-Sided) 95%
-32.94 to 40.44
Estimation Comments Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.
6.Secondary Outcome
Title Combined Rate of Complete or Partial Effectiveness of Combined GIS Management Strategies
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Pradaxa, 30 Minutes After a Meal (Randomized) Pantoprazole 40 mg (Randomized)
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 14 15
Measure Type: Number
Unit of Measure: percentage of participants
85.7 80.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pradaxa, 30 Minutes After a Meal (Randomized), Pantoprazole 40 mg (Randomized)
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.71
Confidence Interval (2-Sided) 95%
-41.25 to 28.77
Estimation Comments Exact 95% Confidence interval (CI) and the difference between the two strategies were calculated using the Clopper Pearson approach.
7.Secondary Outcome
Title Rates of Complete Effectiveness of GIS at Each Visit.
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full analysis Set (FAS).
Arm/Group Title Pradaxa, 30 Minutes After a Meal (Randomized) Pantoprazole 40 mg (Randomized)
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 59 58
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (n= 59 , 58) 0.0 0.0
GIS 3 (Week 1, n= 59 , 58) 39.0 51.7
GIS 4 (Week 2, n= 59 , 58) 45.8 55.2
GIS 5 (Week 3, n= 59 , 58) 55.9 60.3
GIS 6 (Week 4, n= 59 , 58) 55.9 67.2
GIS 7 (Week 5, n= 14 , 15) 28.6 40.0
GIS 8 (Week 6, n= 14 , 15) 42.9 40.0
GIS 9 (Week 7, n= 14 , 15) 42.9 33.3
GIS 10 (Week 8, n= 14 , 15) 42.9 33.3
8.Secondary Outcome
Title Rates of Partial Effectiveness of GIS at Each Visit.
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Pradaxa, 30 Minutes After a Meal (Randomized) Pantoprazole 40 mg (Randomized)
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 59 58
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (n= 59 , 58) 0.0 0.0
GIS 3 (Week 1, n= 59 , 58) 16.9 13.8
GIS 4 (Week 2, n= 59 , 58) 13.6 24.1
GIS 5 (Week 3, n= 59 , 58) 8.5 22.4
GIS 6 (Week 4, n= 59 , 58) 11.9 19.0
GIS 7 (Week 5, n= 14 , 15) 21.4 40.0
GIS 8 (Week 6, n= 14 , 15) 42.9 40.0
GIS 9 (Week 7, n= 14 , 15) 42.9 46.7
GIS 10 (Week 8, n= 14 , 15) 42.9 46.7
9.Secondary Outcome
Title Rates of Complete or Partial Effectiveness of GIS at Each Visit.
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Pradaxa, 30 Minutes After a Meal (Randomized) Pantoprazole 40 mg (Randomized)
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 59 58
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (n= 59 , 58) 0.0 0.0
GIS 3 (Week 1, n= 59 , 58) 55.9 65.5
GIS 4 (Week 2, n= 59 , 58) 59.3 79.3
GIS 5 (Week 3, n= 59 , 58) 64.4 82.8
GIS 6 (Week 4, n= 59 , 58) 67.8 86.2
GIS 7 (Week 5, n= 14 , 15) 50.0 80.0
GIS 8 (Week 6, n= 14 , 15) 85.7 80.0
GIS 9 (Week 7, n= 14 , 15) 85.7 80.0
GIS 10 (Week 8, n= 14 , 15) 85.7 80.0
10.Secondary Outcome
Title Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS)
Arm/Group Title Pradaxa, 30 Minutes After a Meal (Randomized) Pantoprazole 40 mg (Randomized)
Hide Arm/Group Description:
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).
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).
Overall Number of Participants Analyzed 59 58
Mean (Standard Deviation)
Unit of Measure: days
Duration of GIS (N= 58; 58) 23.5  (25.67) 23.9  (25.35)
Time to first complete effectiveness (N= 43; 50) 12.1  (13.45) 10.7  (10.23)
Time to first partial effectiveness(N= 6; 2) 23.7  (15.50) 3.5  (2.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pradaxa, 30 Minutes After a Meal (Randomized), Pantoprazole 40 mg (Randomized)
Comments Mean difference for the Duration of gastrointestinal symptoms (GIS).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-9.9 to 8.9
Estimation Comments Mean difference = (Mean number of days for Pradaxa w/meal) − (Mean number of days for pantoprazole).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Pradaxa, 30 Minutes After a Meal (Randomized), Pantoprazole 40 mg (Randomized)
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-3.5 to 6.3
Estimation Comments Mean difference = (Mean number of days for Pradaxa w/meal) − (Mean number of days for pantoprazole).
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Pradaxa, 30 Minutes After a Meal (Randomized), Pantoprazole 40 mg (Randomized)
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 20.2
Confidence Interval (2-Sided) 95%
-8.2 to 48.5
Estimation Comments Mean difference = (Mean number of days for Pradaxa w/meal) − (Mean number of days for pantoprazole).
Time Frame From first drug administration until 6 days after end of trial, up to 158 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pradaxa, 30 Minutes After a Meal (Randomized) Pantoprazole 40 mg (Randomized) Pradaxa, Never Randomized
Hide Arm/Group Description 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). 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). Patients who were treated for 3 months with Pradaxa ® and were never randomized to management strategies.
All-Cause Mortality
Pradaxa, 30 Minutes After a Meal (Randomized) Pantoprazole 40 mg (Randomized) Pradaxa, Never Randomized
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pradaxa, 30 Minutes After a Meal (Randomized) Pantoprazole 40 mg (Randomized) Pradaxa, Never Randomized
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/59 (3.39%)   3/58 (5.17%)   109/950 (11.47%) 
Blood and lymphatic system disorders       
Anaemia  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Haemorrhagic anaemia  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Cardiac disorders       
Acute coronary syndrome  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Acute myocardial infarction  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Angina pectoris  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Atrial fibrillation  1  1/59 (1.69%)  2/58 (3.45%)  22/950 (2.32%) 
Atrial flutter  1  0/59 (0.00%)  0/58 (0.00%)  4/950 (0.42%) 
Atrial tachycardia  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Atrioventricular block complete  1  0/59 (0.00%)  0/58 (0.00%)  2/950 (0.21%) 
Cardiac arrest  1  1/59 (1.69%)  0/58 (0.00%)  2/950 (0.21%) 
Cardiac failure congestive  1  0/59 (0.00%)  1/58 (1.72%)  21/950 (2.21%) 
Cardiac tamponade  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Coronary artery disease  1  0/59 (0.00%)  0/58 (0.00%)  3/950 (0.32%) 
Mitral valve incompetence  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Mitral valve prolapse  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Myocardial ischaemia  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Palpitations  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Pericardial effusion  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Sick sinus syndrome  1  0/59 (0.00%)  0/58 (0.00%)  4/950 (0.42%) 
Sinus bradycardia  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Ventricular tachycardia  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Congenital, familial and genetic disorders       
Congenital cyst  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Ear and labyrinth disorders       
Vertigo  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Eye disorders       
Diplopia  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Gastrointestinal disorders       
Colon dysplasia  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Dysphagia  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Gastritis  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Gastritis erosive  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Gastrointestinal haemorrhage  1  0/59 (0.00%)  0/58 (0.00%)  2/950 (0.21%) 
Large intestine polyp  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Small intestinal obstruction  1  0/59 (0.00%)  1/58 (1.72%)  0/950 (0.00%) 
Upper gastrointestinal haemorrhage  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
General disorders       
Chest pain  1  0/59 (0.00%)  0/58 (0.00%)  5/950 (0.53%) 
Oedema peripheral  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Pain  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Pyrexia  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Systemic inflammatory response syndrome  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Hepatobiliary disorders       
Cholelithiasis  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Immune system disorders       
Anaphylactic reaction  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Infections and infestations       
Bronchitis  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Cellulitis  1  0/59 (0.00%)  0/58 (0.00%)  2/950 (0.21%) 
Gangrene  1  0/59 (0.00%)  0/58 (0.00%)  2/950 (0.21%) 
Gastroenteritis  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Lobar pneumonia  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Mastitis  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Oesophageal candidiasis  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Pneumonia  1  0/59 (0.00%)  0/58 (0.00%)  5/950 (0.53%) 
Staphylococcal sepsis  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Urinary tract infection  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Injury, poisoning and procedural complications       
Fall  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Femur fracture  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Humerus fracture  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Post procedural haemorrhage  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Procedural nausea  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Skull fractured base  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Toxicity to various agents  1  0/59 (0.00%)  0/58 (0.00%)  2/950 (0.21%) 
Wound secretion  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Investigations       
Blood iron decreased  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Blood magnesium decreased  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Electrocardiogram ST segment depression  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Heart rate decreased  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Hepatic enzyme increased  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Troponin increased  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Metabolism and nutrition disorders       
Dehydration  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Diabetes mellitus inadequate control  1  0/59 (0.00%)  0/58 (0.00%)  2/950 (0.21%) 
Hypokalaemia  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Hyponatraemia  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Musculoskeletal and connective tissue disorders       
Bursitis  1  0/59 (0.00%)  0/58 (0.00%)  2/950 (0.21%) 
Muscular weakness  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Anal cancer stage 0  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Bladder cancer  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Breast cancer  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Squamous cell carcinoma of the tongue  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Nervous system disorders       
Cerebral thrombosis  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Cerebrovascular accident  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Embolic stroke  1  0/59 (0.00%)  0/58 (0.00%)  3/950 (0.32%) 
Haemorrhage intracranial  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Haemorrhagic stroke  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Ischaemic stroke  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Syncope  1  0/59 (0.00%)  0/58 (0.00%)  3/950 (0.32%) 
Transient ischaemic attack  1  0/59 (0.00%)  0/58 (0.00%)  2/950 (0.21%) 
Renal and urinary disorders       
Acute prerenal failure  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Renal failure acute  1  0/59 (0.00%)  0/58 (0.00%)  5/950 (0.53%) 
Renal failure chronic  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Urinary retention  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  0/59 (0.00%)  0/58 (0.00%)  3/950 (0.32%) 
Dyspnoea  1  0/59 (0.00%)  0/58 (0.00%)  2/950 (0.21%) 
Hypoxia  1  0/59 (0.00%)  0/58 (0.00%)  2/950 (0.21%) 
Pleural effusion  1  0/59 (0.00%)  0/58 (0.00%)  3/950 (0.32%) 
Pulmonary hypertension  1  0/59 (0.00%)  0/58 (0.00%)  3/950 (0.32%) 
Respiratory arrest  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Respiratory failure  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Surgical and medical procedures       
Cardiac pacemaker insertion  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Vascular disorders       
Hypertensive crisis  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Hypotension  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Peripheral arterial occlusive disease  1  0/59 (0.00%)  0/58 (0.00%)  1/950 (0.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pradaxa, 30 Minutes After a Meal (Randomized) Pantoprazole 40 mg (Randomized) Pradaxa, Never Randomized
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   37/59 (62.71%)   35/58 (60.34%)   161/950 (16.95%) 
Gastrointestinal disorders       
Abdominal discomfort  1  7/59 (11.86%)  13/58 (22.41%)  25/950 (2.63%) 
Abdominal distension  1  8/59 (13.56%)  12/58 (20.69%)  23/950 (2.42%) 
Abdominal pain upper  1  8/59 (13.56%)  10/58 (17.24%)  26/950 (2.74%) 
Constipation  1  3/59 (5.08%)  4/58 (6.90%)  12/950 (1.26%) 
Defaecation urgency  1  4/59 (6.78%)  2/58 (3.45%)  0/950 (0.00%) 
Diarrhoea  1  7/59 (11.86%)  7/58 (12.07%)  30/950 (3.16%) 
Dyspepsia  1  17/59 (28.81%)  15/58 (25.86%)  73/950 (7.68%) 
Epigastric discomfort  1  9/59 (15.25%)  10/58 (17.24%)  18/950 (1.89%) 
Eructation  1  13/59 (22.03%)  10/58 (17.24%)  25/950 (2.63%) 
Faeces hard  1  1/59 (1.69%)  3/58 (5.17%)  1/950 (0.11%) 
Flatulence  1  5/59 (8.47%)  5/58 (8.62%)  14/950 (1.47%) 
Gastrointestinal sounds abnormal  1  4/59 (6.78%)  2/58 (3.45%)  0/950 (0.00%) 
Nausea  1  5/59 (8.47%)  10/58 (17.24%)  31/950 (3.26%) 
Regurgitation  1  9/59 (15.25%)  4/58 (6.90%)  15/950 (1.58%) 
Infections and infestations       
Bronchitis  1  3/59 (5.08%)  1/58 (1.72%)  18/950 (1.89%) 
Nervous system disorders       
Dizziness  1  3/59 (5.08%)  2/58 (3.45%)  20/950 (2.11%) 
Headache  1  1/59 (1.69%)  3/58 (5.17%)  11/950 (1.16%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 17.0
The modest sample size,non-specific nature of symptoms,&reliance on patient self-reporting of their symptoms may contributed some bias to the final result.An open-label design may lead to patient/investigator bias in reporting symptoms.
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.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01493557     History of Changes
Other Study ID Numbers: 1160.128
First Submitted: December 12, 2011
First Posted: December 16, 2011
Results First Submitted: July 6, 2015
Results First Posted: October 5, 2015
Last Update Posted: October 5, 2015