Clinical trial NCT00872534: Endoscopic Evaluation of Upper Gastrointestinal (GI) Mucosal Damage Induced by PL-2200 Versus Aspirin in Healthy Volunteers
Official title: A Randomized, Single-Blind, Endoscopic Evaluation Of Upper GI Mucosal Damage Induced By PL-2200 Versus Aspirin In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Upper Gastrointestinal Mucosal Damage
Keywords: To evaluate the acute gastrointestinal safety of PL-2100.
Lead sponsor: PLx Pharma
Sponsor class: INDUSTRY
First posted: 2009-03-31
Enrollment: 204
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Incidence of Subjects With Gastroduodenal Erosions and Ulcers.
timeFrame: After 7 days of study medication
Secondary outcomes:
Other outcomes:
Locations:
city: Jupiter
country: United States
facility: Jupiter Research
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Digestive Research
state: Oklahoma
city: Altoona
country: United States
facility: Altoona Arthritis and Osteoporosis Center
state: Pennsylvania
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Center For Clinical Research
state: Texas
Study officials:
affiliation: Dallas VA
name: Byron L Cryer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Houston Institute for Clinical Research
name: Frank L Lanza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jupiter Research
name: Michael E Schwartz, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Altoona Arthritis and Osteoporosis Center
name: Alan J Kivitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oklahoma Foundation for Digestive Research
name: Phillip B Miner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Miami Research Associates
name: Howard Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References: