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OpenTrials
Completed

NCT Number: NCT01646814

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

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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Key information

Conditions

Gastroduodenal Ulceration

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jupiter, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PL2200

Drug

PL2200, containing 325 mg aspirin active ingredient

Other names: PL-ASA

Aspirin Tablets

Drug

325 mg aspirin tablets (USP)

Primary outcomes

  1. Incidence of Gastroduodenal Ulcers

    Time frame: 42 Days

    Cumulative Incidence of Gastroduodenal Ulcers Greater than or equal to 3 mm in length with unequivocal depth

Secondary outcomes

  1. Number of Subjects With Erosion and Ulcers

    Time frame: 42 days

    >5 erosions or ulcers 3 mm or greater in length with unequivocal depth, by endoscopy

Sponsors and collaborators

Lead sponsor

PLx Pharma

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 20, 2012
Registry last updated
Jun 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.