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

NCT01646814 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2022-06-07

Study results available
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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.

Conditions

  • Gastroduodenal Ulceration

Interventions

DRUG

PL2200

PL2200, containing 325 mg aspirin active ingredient

DRUG

Aspirin tablets

325 mg aspirin tablets (USP)

Sponsors & Collaborators

  • PLx Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01646814 on ClinicalTrials.gov