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COMPLETEDPHASE2

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

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

NCT01139190•PLx Pharma

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

50 - 75 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (2)

Dallas VA Medical Center

Dallas, Texas, United States

Houston Center For Clinical Research

Houston, Texas, United States

Key Dates

Start Date

July 1, 2010

Primary Completion Date

December 1, 2010

Completion Date

December 1, 2010

Last Updated

April 11, 2016

Enrollment

ACTUAL participants

Conditions

Gastroduodenal UlcerationsErosion

Interventions

PL3100

DRUG

Naproxen

DRUG

Clinical Study to Assess the Efficacy of New Toothpaste Containing SnF as Compared to Colgate Cavity Protection Toothpaste on the Reduction of Enamel Erosion

NCT07442136

Enamel Erosion

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RECRUITINGNA

Hydroxyapatite Toothpastes and Enamel Remineralization:

NCT07069218

Enamel HypomineralizationTooth Erosion

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COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 11, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Clinical Study to Assess the Efficacy of New Toothpaste Containing SnF as Compared to Colgate Cavity Protection Toothpaste on the Reduction of Enamel Erosion

Hydroxyapatite Toothpastes and Enamel Remineralization:

Effect of Smoking on Saliva Composition and the Development of Dental Erosion

Influence of Gender Specific Differences of Saliva Composition on the Development of Dental Erosion - an In-situ Study

In Situ Erosion Study to Investigate the Effectiveness of an Experimental Toothpaste

Identification of Novel Molecular Targets for Rheumatoid Arthritis Patients