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

PLx Pharma

Status and phase: Completed; Phase 2

Conditions: Erosion; Gastroduodenal Ulcerations

Treatments: Drug: Naproxen; Drug: PL3100

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT01139190

1RC3AR059535-01 (U.S. NIH Grant/Contract)

PL-NAP-002

Details and patient eligibility

About

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

Enrollment: 77 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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77 participants in 2 patient groups

PL3100

Experimental group

Treatment:

Drug: PL3100

Naproxen

Active Comparator group

Treatment:

Drug: Naproxen