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

This study has been completed.
Sponsor:
Information provided by:
PLx Pharma
ClinicalTrials.gov Identifier:
NCT00872534
First received: March 10, 2009
Last updated: July 28, 2009
Last verified: May 2009
  Purpose

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 Intervention Phase
Upper Gastrointestinal Mucosal Damage
Drug: acetylsalicylic acid
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by PLx Pharma:

Primary Outcome Measures:
  • Incidence of subjects with gastroduodenal erosions and ulcers. [ Time Frame: After 7 days of study medication ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of subjects with ulcers (ulcers 3mm or greater in length with unequivocal depth). [ Time Frame: After 7 days of study medication ] [ Designated as safety issue: No ]
  • Mean number of erosions in the duodenum and stomach. [ Time Frame: After 7 days of study medication ] [ Designated as safety issue: No ]

Estimated Enrollment: 164
Study Start Date: January 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
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
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: NCT00872534

Locations
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
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

No publications provided

Responsible Party: Upendra Marathi, Senior Vice President, PLx Pharma
ClinicalTrials.gov Identifier: NCT00872534     History of Changes
Other Study ID Numbers: PL-ASA-002
Study First Received: March 10, 2009
Last Updated: July 28, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by PLx Pharma:
To evaluate the acute gastrointestinal safety of PL-2100.

Additional relevant MeSH terms:
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 01, 2014