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Endoscopic Evaluation of Upper Gastrointestinal (GI) Mucosal Damage Induced by PL-2200 Versus Aspirin in Healthy Volunteers

NCT00872534 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2015-08-11

Study results available
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Summary

To determine the gastrointestinal safety of PL-2200 versus immediate-release aspirin by assessing endoscopic gastroduodenal mucosal injury at approved daily cardiac-protective doses of aspirin (325 mg) in normal healthy volunteers.

Conditions

  • Upper Gastrointestinal Mucosal Damage

Interventions

DRUG

acetylsalicylic acid

325mg once a day for 7 days

Sponsors & Collaborators

  • PLx Pharma

    lead INDUSTRY

Principal Investigators

  • Byron L Cryer, MD · Dallas VA

  • Frank L Lanza, MD · Houston Institute for Clinical Research

  • Michael E Schwartz, DO · Jupiter Research

  • Alan J Kivitz, MD · Altoona Arthritis and Osteoporosis Center

  • Phillip B Miner, MD · Oklahoma Foundation for Digestive Research

  • Howard Schwartz, MD · Miami Research Associates

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-07-31
Completion
2009-07-31

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 NCT00872534 on ClinicalTrials.gov