Trial · NCT01493557
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
NCT01493557, Phase 4, Completed, Boehringer Ingelheim; results first posted 2015-10-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT01493557. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01493557
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT01493557
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,067 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Atrial Fibrillation
- Interventions
- pantoprazole, Pradaxa (dabigatran etexilate), Pradaxa, within 30 minutes after a meal, Pradaxa (dabigatran etexilate)
- First posted
- 2011-12-16
- Last updated
- 2015-10-05
- Results first posted
- 2015-10-05
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Rate of Complete Effectiveness of Initial GIS Management Strategy | Week 4 | Full Analysis Set (FAS): This patient set included all patients who developed GIS and who were randomized into the two management strategies. | percentage of participants | NUMBER |
| SECONDARY | Rate of Partial Effectiveness of Initial GIS Management Strategies | Week 4 | Full Analysis Set (FAS) | percentage of participants | NUMBER |
| SECONDARY | Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies | Week 4 | Full Analysis Set (FAS) | percentage of participants | NUMBER |
| SECONDARY | Rate of Complete Effectiveness of Combined GIS Management Strategies | Week 8 | Full Analysis Set (FAS) | percentage of participants | NUMBER |
| SECONDARY | Rate of Partial Effectiveness of Combined GIS Management Strategies | Week 8 | Full Analysis Set (FAS) | percentage of participants | NUMBER |
| SECONDARY | Combined Rate of Complete or Partial Effectiveness of Combined GIS Management Strategies | Week 8 | Full Analysis Set (FAS) | percentage of participants | NUMBER |
| SECONDARY | 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 | Full analysis Set (FAS). | percentage of participants | NUMBER |
| SECONDARY | 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 | Full Analysis Set (FAS) | percentage of participants | NUMBER |
| SECONDARY | 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 | Full Analysis Set (FAS). | percentage of participants | NUMBER |
| SECONDARY | Time Between Symptom Onset and First Observed Complete or Partial Effectiveness and Between Symptom Onset and Last Observed Symptom | Week 8 | Full Analysis Set (FAS) | days | MEAN |
Source ClinicalTrials.gov
Results by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Rate of Complete Effectiveness of Initial GIS Management Strategy | Pradaxa, 30 Minutes After a Meal (Randomized) | 55.9 | percentage of participants | ||
| The Rate of Complete Effectiveness of Initial GIS Management Strategy | Pantoprazole 40 mg (Randomized) | 67.2 | percentage of participants | ||
| Rate of Partial Effectiveness of Initial GIS Management Strategies | Pradaxa, 30 Minutes After a Meal (Randomized) | 11.9 | percentage of participants | ||
| Rate of Partial Effectiveness of Initial GIS Management Strategies | Pantoprazole 40 mg (Randomized) | 19.0 | percentage of participants | ||
| Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies | Pradaxa, 30 Minutes After a Meal (Randomized) | 67.8 | percentage of participants | ||
| Combined Rate of Complete or Partial Effectiveness of Initial GIS Management Strategies | Pantoprazole 40 mg (Randomized) | 86.2 | percentage of participants | ||
| Rate of Complete Effectiveness of Combined GIS Management Strategies | Pradaxa, 30 Minutes After a Meal (Randomized) | 42.9 | percentage of participants | ||
| Rate of Complete Effectiveness of Combined GIS Management Strategies | Pantoprazole 40 mg (Randomized) | 33.3 | percentage of participants | ||
| Rate of Partial Effectiveness of Combined GIS Management Strategies | Pradaxa, 30 Minutes After a Meal (Randomized) | 42.9 | percentage of participants | ||
| Rate of Partial Effectiveness of Combined GIS Management Strategies | Pantoprazole 40 mg (Randomized) | 46.7 | percentage of participants |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Not Randomized to Management Strategies | STARTED | Pradaxa, 30 Minutes After a Meal (Randomized) | 0 | |
| Not Randomized to Management Strategies | STARTED | Pantoprazole 40 mg (Randomized) | 0 | |
| Not Randomized to Management Strategies | STARTED | Pradaxa, Never Randomized | 950 | |
| Not Randomized to Management Strategies | Without Experiencing GIS | Pradaxa, 30 Minutes After a Meal (Randomized) | 0 | |
| Not Randomized to Management Strategies | Without Experiencing GIS | Pantoprazole 40 mg (Randomized) | 0 | |
| Not Randomized to Management Strategies | Without Experiencing GIS | Pradaxa, Never Randomized | 854 | |
| Not Randomized to Management Strategies | Reported GIS Prior to EOT Visit | Pradaxa, 30 Minutes After a Meal (Randomized) | 0 | |
| Not Randomized to Management Strategies | Reported GIS Prior to EOT Visit | Pantoprazole 40 mg (Randomized) | 0 | |
| Not Randomized to Management Strategies | Reported GIS Prior to EOT Visit | Pradaxa, Never Randomized | 48 | |
| Not Randomized to Management Strategies | Reported GIS Only at EOT Visit | Pradaxa, 30 Minutes After a Meal (Randomized) | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events339
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal discomfort | Gastrointestinal disorders | Pradaxa, 30 Minutes After a Meal (Randomized) | 7 | 59 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Pantoprazole 40 mg (Randomized) | 13 | 58 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Pradaxa, Never Randomized | 25 | 950 | |
| other | Abdominal distension | Gastrointestinal disorders | Pradaxa, 30 Minutes After a Meal (Randomized) | 8 | 59 | |
| other | Abdominal distension | Gastrointestinal disorders | Pantoprazole 40 mg (Randomized) | 12 | 58 | |
| other | Abdominal distension | Gastrointestinal disorders | Pradaxa, Never Randomized | 23 | 950 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Pradaxa, 30 Minutes After a Meal (Randomized) | 8 | 59 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Pantoprazole 40 mg (Randomized) | 10 | 58 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Pradaxa, Never Randomized | 26 | 950 | |
| other | Constipation | Gastrointestinal disorders | Pradaxa, 30 Minutes After a Meal (Randomized) | 3 | 59 |
1 to 10 of 339Source ClinicalTrials.gov
See all 339 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pradaxa, 30 Minutes After a Meal (Randomized) | ||
| Total, all-cause mortality | Pantoprazole 40 mg (Randomized) | ||
| Total, all-cause mortality | Pradaxa, Never Randomized | ||
| Total, other adverse events | Pradaxa, 30 Minutes After a Meal (Randomized) | 37 | 59 |
| Total, other adverse events | Pantoprazole 40 mg (Randomized) | 35 | 58 |
| Total, other adverse events | Pradaxa, Never Randomized | 161 | 950 |
| Total, serious adverse events | Pradaxa, 30 Minutes After a Meal (Randomized) | 2 | 59 |
| Total, serious adverse events | Pantoprazole 40 mg (Randomized) | 3 | 58 |
| Total, serious adverse events | Pradaxa, Never Randomized | 109 | 950 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27709460 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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