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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PLx Pharma
ClinicalTrials.gov Identifier:
NCT01646814
First received: July 18, 2012
Last updated: August 18, 2014
Last verified: August 2014
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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:
  • Gastroduodenal ulcer incidence [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: PLx Pharma
ClinicalTrials.gov Identifier: NCT01646814     History of Changes
Other Study ID Numbers: PL-ASA-005
Study First Received: July 18, 2012
Last Updated: August 18, 2014
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014