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

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.
 
ClinicalTrials.gov Identifier: NCT00872534
Recruitment Status : Completed
First Posted : March 31, 2009
Results First Posted : August 11, 2015
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
PLx Pharma

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Upper Gastrointestinal Mucosal Damage Drug: acetylsalicylic acid Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Single-Blind, Endoscopic Evaluation Of Upper GI Mucosal Damage Induced By PL-2200 Versus Aspirin In Healthy Volunteers
Study Start Date : January 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arms and Interventions
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Arm Intervention/treatment
Experimental: PL-2200
PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.
 Drug: acetylsalicylic acid
325mg once a day for 7 days
Active Comparator: Aspirin
Immediate release 325mg aspirin
 Drug: acetylsalicylic acid
325mg once a day for 7 days


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Subjects With Gastroduodenal Erosions and Ulcers. [ Time Frame: After 7 days of study medication ]
    Incidence of subjects with gastroduodenal composite scores of 3 or 4 (> 5 erosions or 1 or more ulcers 3 mm or greater in length with unequivocal depth).


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • Subject is ≥50 to ≤75 years of age.
  • Subject is healthy.
  • Subject has a BMI between 20 and 32
  • If female and of child bearing potential, subject has a negative pregnancy test and is not nursing.

Exclusion Criteria:

  • Subject has abnormal screening/baseline laboratory parameters or endoscopic observations deemed clinically significant by the Investigator.
  • Subject has an active Helicobacter pylori infection.
  • Subject has a prior GI ulcer, bleeding, obstruction or perforation.
  • Subject has taken aspirin or any aspirin containing product within the last 4 weeks, or a non-aspirin NSAID product within 2 weeks.
  • Subject has taken any of the following medications within 2 weeks prior to enrollment: Any anti-platelet agents, anti-coagulants or selective serotonin reuptake inhibitors.
  • Subject has used an investigational agent within the past 30 days.
  • Subject has hypersensitivity or contraindications to aspirin, ibuprofen, or other NSAID.
Contacts and Locations
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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): NCT00872534


Locations
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United States, Florida
Jupiter Research
Jupiter, Florida, United States
Miami Research Associates
South Miami, Florida, United States
United States, Oklahoma
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Altoona Arthritis and Osteoporosis Center
Altoona, Pennsylvania, United States
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States
Houston Center For Clinical Research
Houston, Texas, United States
Sponsors and Collaborators
PLx Pharma
Investigators
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Principal Investigator: Byron L Cryer, MD Dallas VA
Principal Investigator: Frank L Lanza, MD Houston Institute for Clinical Research
Principal Investigator: Michael E Schwartz, DO Jupiter Research
Principal Investigator: Alan J Kivitz, MD Altoona Arthritis and Osteoporosis Center
Principal Investigator: Phillip B Miner, MD Oklahoma Foundation for Digestive Research
Principal Investigator: Howard Schwartz, MD Miami Research Associates
More Information
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Responsible Party: PLx Pharma
ClinicalTrials.gov Identifier: NCT00872534    
Other Study ID Numbers: PL-ASA-002
First Posted: March 31, 2009    Key Record Dates
Results First Posted: August 11, 2015
Last Update Posted: August 11, 2015
Last Verified: August 2015
Keywords provided by PLx Pharma:
To evaluate the acute gastrointestinal safety of PL-2100.
Additional relevant MeSH terms:
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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