Phase 2
N=204
Endoscopic Evaluation of Upper Gastrointestinal (GI) Mucosal Damage Induced by PL-2200 Versus Aspirin in Healthy Volunteers
Upper Gastrointestinal Mucosal Damage
Bottom Line
View on ClinicalTrials.gov: NCT00872534 ↗Enrolled (actual)
204
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: Incidence of Subjects With Gastroduodenal Erosions and Ulcers. — 72; 54; 19; 36 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- acetylsalicylic acid (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- PLx Pharma
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Subjects With Gastroduodenal Erosions and Ulcers. |
72; 54; 19; 36 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00872534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.