CompletedPhase 2

Clinical Trial Evaluating Gastrointestinal Damage Following Administration PL3100 or Naproxen in At-Risk Adults

United States77 participantsStarted 2010-07

Plain-language summary

The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of PL3100 versus Naproxen in normal healthy volunteers.

Who can participate

Age range50 Years – 75 Years

SexALL

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Inclusion Criteria (Selected) * Male and female healthy adult subjects Exclusion Criteria (Selected) * Subject has protocol specified significant medical history. * Subject is currently participating, or has participated within 30 days prior to study entry, in an investigational drug study. * Subject has hypersensitivity or contraindications to naproxen, ibuprofen, or other NSAID.

What they're measuring

Degree of GI Injury at Day 15

Timeframe: 15 days

Trial details

NCT IDNCT01139190

SponsorPLx Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-12

Results submitted2015-06-22

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