NCT00872534

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2009

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 31, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
6.1 years until next milestone

Results Posted

Study results publicly available

August 11, 2015

Completed
Last Updated

August 11, 2015

Status Verified

August 1, 2015

Enrollment Period

6 months

First QC Date

March 10, 2009

Results QC Date

June 22, 2015

Last Update Submit

August 5, 2015

Conditions

Upper Gastrointestinal Mucosal Damage

Keywords

To evaluate the acute gastrointestinal safety of PL-2100.

Outcome Measures

Primary Outcomes (1)

  • Incidence of Subjects With Gastroduodenal Erosions and Ulcers.

    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).

    After 7 days of study medication

Study Arms (2)

PL-2200

EXPERIMENTAL

PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.

Drug: acetylsalicylic acid

Aspirin

ACTIVE COMPARATOR

Immediate release 325mg aspirin

Drug: acetylsalicylic acid

Interventions

acetylsalicylic acidDRUG

325mg once a day for 7 days

AspirinPL-2200

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Jupiter Research

Jupiter, Florida, United States

Location

Miami Research Associates

South Miami, Florida, United States

Location

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, United States

Location

Altoona Arthritis and Osteoporosis Center

Altoona, Pennsylvania, United States

Location

Dallas VA Medical Center

Dallas, Texas, United States

Location

Houston Center For Clinical Research

Houston, Texas, United States

Location

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Ronald Zimmerman, CEO & President
Organization
PLx Pharma
ron.zimmerman@plxpharma.com
1-713-842-1249

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2009

First Posted

March 31, 2009

Study Start

January 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

August 11, 2015

Results First Posted

August 11, 2015

Record last verified: 2015-08

Locations

US(6)