Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers
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|ClinicalTrials.gov Identifier: NCT00960869|
Recruitment Status : Completed
First Posted : August 18, 2009
Results First Posted : February 17, 2016
Last Update Posted : February 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Gastric Ulcer||Drug: PA32540 Drug: EC-Aspirin 325 mg||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||519 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole
Other Name: YOSPRALA
Active Comparator: EC-Aspirin 325 mg
EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
Drug: EC-Aspirin 325 mg
The comparator aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole)
- Number of Participants With Gastric Ulcer Confirmed by Endoscopy [ Time Frame: 6 months ]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.
- The Number of Participants With Gastric and/or Duodenal Ulcers [ Time Frame: 6 months ]The Number of Participants with Gastric and/or Duodenal Ulcers throughout 6 months of treatment.
- The Number of Subjects With "Treatment Success" [ Time Frame: 6 months ]Those Subjects Without Gastric Ulcers and Without Upper Gastrointestinal (UGI) Adverse Events leading to discontinuation.
- The Number of Participants Discontinuing From the Study Due to NSAID-Associated Upper GI Adverse Events [ Time Frame: 6 months ]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
- The Number of Participants With Heartburn Resolution at 6 Months, i.e. no Heartburn Symptoms During the Last 7 Days Prior to the Visit [ Time Frame: 6 months ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00960869
|United States, North Carolina|
|Chapel Hill, North Carolina, United States, 27519|