At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 77 enrolled
Drug / intervention
PL3100 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Clinical Trial Evaluating the Incidence of Upper Gastrointestinal Mucosal Damage Following Administration of Either PL3100 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated GI Damage
In Brief
A Phase 2 clinical trial evaluating PL3100 and Naproxen for Gastroduodenal Ulcerations and Erosion. Completed, enrolled 77 participants across 2 sites.
Detailed Summary
The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of PL3100 versus Naproxen in normal healthy volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastroduodenal Ulcerations, Erosion
CountriesUnited States
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2010
Enrollment StartJul 2010
Primary CompletionDec 2010
TodayJul 2026
First PostedJun 8, 2010
Enrollment StartJul 1, 2010
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.1 years ago
Interventions
PL3100drug
Oral administration
Naproxendrug
Oral administration