Trial Outcomes & Findings for Optimal Dose of Proton Pump Inhibitors Following an Upper Gastrointestinal Bleed (NCT NCT02235311)
NCT ID: NCT02235311
Last Updated: 2017-07-31
Results Overview
as defined by follow-up endoscopy per gastroenterology service, 8 weeks after UGIB acute management
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
8 weeks
Results posted on
2017-07-31
Participant Flow
Three participants signed the consent form. One went on to complete the study; 1 was terminated by PI before starting the treatment and 1 was lost to follow-up before starting the treatment.
Participant milestones
| Measure |
Pantoprazole Twice Daily
Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB
|
Pantoprazole Once Daily
Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
2
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Pantoprazole Twice Daily
Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB
|
Pantoprazole Once Daily
Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pantoprazole Twice Daily
n=1 Participants
Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB
|
Pantoprazole Once Daily
Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age >18 years
|
1 Participants
n=1 Participants
|
0 Participants
|
1 Participants
n=1 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=1 Participants
|
0 Participants
|
1 Participants
n=1 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
1 participants
n=1 Participants
|
—
|
1 participants
n=1 Participants
|
|
Weight
|
140 kg
n=1 Participants
|
—
|
140 kg
n=1 Participants
|
|
Glasgow-Blatchford Score
|
17 summary score
STANDARD_DEVIATION NA • n=1 Participants
|
—
|
17 summary score
STANDARD_DEVIATION NA • n=1 Participants
|
|
Heart rate
|
105 bpm
STANDARD_DEVIATION NA • n=1 Participants
|
—
|
105 bpm
STANDARD_DEVIATION NA • n=1 Participants
|
|
Participants with orthostasis
|
0 participants
n=1 Participants
|
—
|
0 participants
n=1 Participants
|
|
Mean arterial pressure (MAP)
|
76 mm Hg
STANDARD_DEVIATION NA • n=1 Participants
|
—
|
76 mm Hg
STANDARD_DEVIATION NA • n=1 Participants
|
|
Platelets
|
299 Platelets/mm^3
STANDARD_DEVIATION NA • n=1 Participants
|
—
|
299 Platelets/mm^3
STANDARD_DEVIATION NA • n=1 Participants
|
|
Blood urea nitrogen (BUN)
|
25 mg/dl
STANDARD_DEVIATION NA • n=1 Participants
|
—
|
25 mg/dl
STANDARD_DEVIATION NA • n=1 Participants
|
|
Serum creatinine (SCr)
|
0.7 mg/dL
STANDARD_DEVIATION NA • n=1 Participants
|
—
|
0.7 mg/dL
STANDARD_DEVIATION NA • n=1 Participants
|
|
Positive fecal occult blood test (FOBT)
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=1 Participants
|
|
H. pylori (serum) positive
|
0 Participants
n=1 Participants
|
0 Participants
|
0 Participants
n=1 Participants
|
|
Appearance of ulcer (clean-based)
|
1 Participants
n=1 Participants
|
—
|
1 Participants
n=1 Participants
|
|
Appearance of ulcer (oozing, bleeding)
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=1 Participants
|
|
Melena present
|
1 Participants
n=1 Participants
|
—
|
1 Participants
n=1 Participants
|
|
Hematemesis present
|
1 Participants
n=1 Participants
|
—
|
1 Participants
n=1 Participants
|
|
Syncope
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=1 Participants
|
|
Hepatic disease
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=1 Participants
|
|
NSAID use
|
1 Participants
n=1 Participants
|
—
|
1 Participants
n=1 Participants
|
|
Warfarin use
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=1 Participants
|
|
Steroid use
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=1 Participants
|
|
Novel oral anticoagulant (NOAC) use
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=1 Participants
|
|
smoker
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=1 Participants
|
|
alcoholism
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=1 Participants
|
|
history of ulcers
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=1 Participants
|
|
history of bleed
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=1 Participants
|
|
endoscopic intervention required
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=1 Participants
|
|
transfusion required
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=1 Participants
|
|
Malignant cause identified
|
0 Participants
n=1 Participants
|
—
|
0 Participants
n=1 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: 1 ulcer located in duodenum, clean-base; randomized single-blinded to proton pump inhibitor (PPI) twice daily
as defined by follow-up endoscopy per gastroenterology service, 8 weeks after UGIB acute management
Outcome measures
| Measure |
Pantoprazole Twice Daily
n=1 Participants
Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB
|
Pantoprazole Once Daily
Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB
|
|---|---|---|
|
Ulcer Healing
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 weeksPer patient report or as defined by follow-up endoscopy per gastroenterology service, 8 weeks after UGIB acute management High clinical suspicion of rebleed includes melena, hematochezia, confirmed by repeat endoscopy, requiring additional management
Outcome measures
| Measure |
Pantoprazole Twice Daily
n=1 Participants
Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB
|
Pantoprazole Once Daily
Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB
|
|---|---|---|
|
Rate of Rebleed
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 weeksClostridium difficile confirmed by polymerase chain reaction (PCR)
Outcome measures
| Measure |
Pantoprazole Twice Daily
n=1 Participants
Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB
|
Pantoprazole Once Daily
Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB
|
|---|---|---|
|
Clostridium Difficile Diarrhea
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 weeksAs defined by clinical suspicion and/or positive sputum culture requiring antibiotic treatment
Outcome measures
| Measure |
Pantoprazole Twice Daily
n=1 Participants
Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB
|
Pantoprazole Once Daily
Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB
|
|---|---|---|
|
Community-Acquired Pneumonia
|
0 Participants
|
0 Participants
|
Adverse Events
Pantoprazole Twice Daily
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pantoprazole Once Daily
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ashley McCormick, PharmD, BCPS
University of Missouri - Columbia
Phone: 573-771-7798
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place