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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Gastroduodenal Ulcerations Erosion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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PL3100

Group Type EXPERIMENTAL

PL3100

Intervention Type DRUG

Oral administration

Naproxen

Group Type ACTIVE_COMPARATOR

Naproxen

Intervention Type DRUG

Oral administration

Interventions

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PL3100

Oral administration

Intervention Type DRUG

Naproxen

Oral administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female healthy adult subjects

Exclusion Criteria

* 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.

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes