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Trial record 1 of 5 for:    PL2200
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Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects

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ClinicalTrials.gov Identifier: NCT01646814
Recruitment Status : Completed
First Posted : July 20, 2012
Results First Posted : October 5, 2015
Last Update Posted : June 7, 2022
Information provided by (Responsible Party):
PLx Pharma

Brief 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.

Condition or disease Intervention/treatment Phase
Gastroduodenal Ulceration Drug: PL2200 Drug: Aspirin tablets Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 247 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Blinded, Endoscopic Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects
Study Start Date : September 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: PL2200
Investigational product, PL2200
Drug: PL2200
PL2200, containing 325 mg aspirin active ingredient
Other Name: PL-ASA

Active Comparator: Aspirin tablets
Active comparator, 325 mg aspirin tablets
Drug: Aspirin tablets
325 mg aspirin tablets (USP)

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01646814

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United States, Florida
Jupiter, Florida, United States
South Miami, Florida, United States
United States, Maryland
Towson, Maryland, United States
United States, New York
New York, New York, United States
United States, North Carolina
High Point, North Carolina, United States
Raleigh, North Carolina, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Chesapeake, Virginia, United States
Sponsors and Collaborators
PLx Pharma
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Responsible Party: PLx Pharma
ClinicalTrials.gov Identifier: NCT01646814    
Other Study ID Numbers: PL-ASA-005
First Posted: July 20, 2012    Key Record Dates
Results First Posted: October 5, 2015
Last Update Posted: June 7, 2022
Last Verified: May 2022
Keywords provided by PLx Pharma:
Healthy volunteer
comparison of incidence of
treatment groups.
Additional relevant MeSH terms:
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Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors