Primary: To demonstrate that PA32540 causes fewer gastric ulcers in subjects at risk for developing aspirin-associated gastric ulcers compared to enteric coated (EC) aspirin 325 mg.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
519
PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole
The comparator aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole)
Pozen
Chapel Hill, North Carolina, United States
Number of Participants With Gastric Ulcer Confirmed by Endoscopy
The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached.
Time frame: 6 months
The Number of Participants With Gastric and/or Duodenal Ulcers
The Number of Participants with Gastric and/or Duodenal Ulcers throughout 6 months of treatment.
Time frame: 6 months
The Number of Subjects With "Treatment Success"
Those Subjects Without Gastric Ulcers and Without Upper Gastrointestinal (UGI) Adverse Events leading to discontinuation.
Time frame: 6 months
The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events
The Number of Participants Discontinuing from the Study Due to non-steroidal anti-inflammatory drug (NSAID)-Associated Upper GI Adverse Events during the treatment period
Time frame: 6 months
The Number of Participants With Heartburn Resolution at 6 Months, i.e. no Heartburn Symptoms During the Last 7 Days Prior to the Visit
Subjects were asked whether heartburn symptoms within the 7 days prior to the visit were: * none: no symptoms * mild: awareness of symptom, but easily tolerated * moderate: discomforting symptom sufficient to cause interference with normal activities (including sleep) * severe: incapacitating symptom, with inability to perform normal activities (including sleep) Heartburn was defined as a burning feeling rising from the stomach or lower part of the chest towards the neck.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6 months