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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

247 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gastroduodenal Ulceration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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PL2200

Investigational product, PL2200

Group Type EXPERIMENTAL

PL2200

Intervention Type DRUG

PL2200, containing 325 mg aspirin active ingredient

Aspirin tablets

Active comparator, 325 mg aspirin tablets

Group Type ACTIVE_COMPARATOR

Aspirin tablets

Intervention Type DRUG

325 mg aspirin tablets (USP)

Interventions

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PL2200

PL2200, containing 325 mg aspirin active ingredient

Intervention Type DRUG

Aspirin tablets

325 mg aspirin tablets (USP)

Intervention Type DRUG

Other Intervention Names

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PL-ASA

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes