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

Phase 3

Completed

• Conditions: Gastric Ulcer
• Interventions: Drug: EC-Aspirin 325 mg; Drug: PA32540

• Registration Number: NCT00960869
• Lead Sponsor: POZEN

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-17
• Study First Submitted QC: 2009-08-17
• Study First Posted: 2009-08-18
• Study Start: 2009-10
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Disposition First Submitted: 2012-10-31
• Disposition First Submitted QC: 2012-10-31
• Disposition First Posted: 2012-11-02
• Results First Submitted: 2015-10-22
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-20
• Last Update Submitted: 2016-01-20
• Results First Posted: 2016-02-17
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 519

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EC-Aspirin 325 mg	EC-Aspirin 325 mg	EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
PA32540	PA32540	PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Gastric Ulcer Confirmed by Endoscopy	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.

Secondary Outcome Measures

Name	Time	Method
The Number of Subjects With "Treatment Success"	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	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	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.
The Number of Participants With Gastric and/or Duodenal Ulcers	6 months	The Number of Participants with Gastric and/or Duodenal Ulcers throughout 6 months of treatment.

Trial Locations

Locations (1)

Pozen; 🇺🇸 Chapel Hill, North Carolina, United States