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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01493557
First received: December 12, 2011
Last updated: September 2, 2015
Last verified: September 2015
Results First Received: July 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Atrial Fibrillation
Interventions: Drug: pantoprazole
Drug: Pradaxa (dabigatran etexilate)
Drug: Pradaxa, within 30 minutes after a meal

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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).
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).
Pradaxa, Never Randomized Patients who were treated for 3 months with Pradaxa ® and were never randomized to management strategies.

Participant Flow for 3 periods

Period 1:   Not Randomized to Management Strategies
    Pradaxa, 30 Minutes After a Meal (Randomized)     Pantoprazole 40 mg (Randomized)     Pradaxa, Never Randomized  
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  
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 2:   Randomized to Management Strategies
    Pradaxa, 30 Minutes After a Meal (Randomized)     Pantoprazole 40 mg (Randomized)     Pradaxa, Never Randomized  
STARTED     59     58     0  
COMPLETED     44     47     0  
NOT COMPLETED     15     11     0  
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 3:   Adding the Second Strategy
    Pradaxa, 30 Minutes After a Meal (Randomized)     Pantoprazole 40 mg (Randomized)     Pradaxa, Never Randomized  
STARTED     14     15     0  
COMPLETED     12     11     0  
NOT COMPLETED     2     4     0  
Worsening of events associate with GIS                 1                 1                 0  
Other adverse event                 1                 2                 0  
Withdrawal by Subject                 0                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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).
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).
Pradaxa, Never Randomized Patients who were treated for 3 months with Pradaxa ® and were never randomized to management strategies.
Total Total of all reporting groups

Baseline Measures
    Pradaxa, 30 Minutes After a Meal (Randomized)     Pantoprazole 40 mg (Randomized)     Pradaxa, Never Randomized     Total  
Number of Participants  
[units: participants]
  59     58     950     1067  
Age  
[units: Years]
Mean (Standard Deviation)
  69.1  (11.1)     69.6  (10.8)     69.7  (10.7)     69.7  (10.7)  
Gender  
[units: participants]
       
Female     22     20     304     346  
Male     37     38     646     721  



  Outcome Measures
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1.  Primary:   The Rate of Complete Effectiveness of Initial GIS Management Strategy   [ Time Frame: Week 4 ]

2.  Secondary:   Rate of Partial Effectiveness of Initial GIS Management Strategies   [ Time Frame: Week 4 ]

3.  Secondary:   Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies   [ Time Frame: Week 4 ]

4.  Secondary:   Rate of Complete Effectiveness of Combined GIS Management Strategies   [ Time Frame: Week 8 ]

5.  Secondary:   Rate of Partial Effectiveness of Combined GIS Management Strategies   [ Time Frame: Week 8 ]

6.  Secondary:   Combined Rate of Complete or Partial Effectiveness of Combined GIS Management Strategies   [ Time Frame: Week 8 ]

7.  Secondary:   Rates of Complete Effectiveness of GIS at Each Visit.   [ Time Frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8 ]

8.  Secondary:   Rates of Partial Effectiveness of GIS at Each Visit.   [ Time Frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8 ]

9.  Secondary:   Rates of Complete or Partial Effectiveness of GIS at Each Visit.   [ Time Frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 & Week 8 ]

10.  Secondary:   Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom   [ Time Frame: Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com



Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01493557     History of Changes
Other Study ID Numbers: 1160.128
Study First Received: December 12, 2011
Results First Received: July 6, 2015
Last Updated: September 2, 2015
Health Authority: Canada: Health Canada
United States: Institutional Review Board