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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01646814
First Posted: July 20, 2012
Last Update Posted: October 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
PLx Pharma
  Purpose
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. 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.

Condition Intervention Phase
Gastroduodenal Ulceration Drug: PL2200 Drug: Aspirin tablets Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by PLx Pharma:

Primary Outcome Measures:
  • 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


Enrollment: 247
Study Start Date: September 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PL2200
Investigational product, PL2200
Drug: PL2200
PL2200, containing 325 mg aspirin active ingredient
Active Comparator: Aspirin tablets
Active comparator, 325 mg aspirin tablets
Drug: Aspirin tablets
325 mg aspirin tablets (USP)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
  Contacts and Locations
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


Locations
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
Cheseapeake, Virginia, United States
Sponsors and Collaborators
PLx Pharma
  More Information

Responsible Party: PLx Pharma
ClinicalTrials.gov Identifier: NCT01646814     History of Changes
Other Study ID Numbers: PL-ASA-005
First Submitted: July 18, 2012
First Posted: July 20, 2012
Results First Submitted: June 18, 2015
Results First Posted: October 5, 2015
Last Update Posted: October 5, 2015
Last Verified: September 2015

Keywords provided by PLx Pharma:
Healthy volunteer
comparison of incidence of
treatment groups.

Additional relevant MeSH terms:
Ulcer
Pathologic Processes
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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
Antipyretics