Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects

Gastroduodenal Ulceration Clinical Trial

Official title:

A Randomized, Blinded, Endoscopic Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01646814
• Other study ID #: PL-ASA-005
• Status: Completed
• Phase: Phase 2
• Start date: September 2012
• Est. completion date: June 2013

Study information

• Verified date: May 2022
• Source: PLx Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is a Phase 2, randomized, controlled study to compare the degree of mucosal injury after the oral administration of an investigational product, PL2200, and a marketed 325 mg immediate-release aspirin product.

Description:

Each group will be treated with either an immediate-release aspirin tablet or PL2200 capsule at 325 mg per day for 6 weeks, and evaluated via an endoscope for any gastrointestinal injury that may have been caused by study medication.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers, =50 and =75 years of age.

• No endoscopically observed baseline gastrointestinal lesions.

Exclusion Criteria:

• Baseline gastrointestinal lesions or abnormal screening/baseline laboratory parameters deemed clinically significant by the Investigator.

• Significant history of substance abuse or uncontrolled acute or chronic medical illness.

• Active H. pylori infection.

• Current use of low-dose aspirin for cardioprevention, or other ulcerogenic medications, gastroprotective, or anti-platelet agents.

• Hypersensitivity to aspirin or other NSAIDs.

Related Conditions & MeSH terms

• Gastroduodenal Ulceration
• Ulcer

Intervention

Drug:
• PL2200
PL2200, containing 325 mg aspirin active ingredient
• Aspirin tablets
325 mg aspirin tablets (USP)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
PLx Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Gastroduodenal Ulcers	Cumulative Incidence of Gastroduodenal Ulcers Greater than or equal to 3 mm in length with unequivocal depth	42 Days
Secondary	Number of Subjects With Erosion and Ulcers	>5 erosions or ulcers 3 mm or greater in length with unequivocal depth, by endoscopy	42 days