Completed

NCT Number: NCT00872534

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Upper Gastrointestinal Mucosal Damage

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Jupiter Research, Jupiter, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

acetylsalicylic acid

Drug

325mg once a day for 7 days

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

PLx Pharma

Industry

Registry information

Official study title

A Randomized, Single-Blind, Endoscopic Evaluation Of Upper GI Mucosal Damage Induced By PL-2200 Versus Aspirin In Healthy Volunteers

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Mar 31, 2009
Registry last updated: Aug 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.