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

This study has been completed.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
PLx Pharma Identifier:
First received: June 4, 2010
Last updated: March 28, 2016
Last verified: March 2016
The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of PL3100 versus Naproxen in normal healthy volunteers.

Condition Intervention Phase
Gastroduodenal Ulcerations
Drug: PL3100
Drug: Naproxen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

Further study details as provided by PLx Pharma:

Primary Outcome Measures:
  • Degree of GI Injury at Day 15 [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

    Degree of mucosal injury was assessed by endoscopy, with the following scoring system:

    Score 0: No Injury Score 1: 1 to 10 petechiae Score 2: > 10 petechiae or 1 to 5 erosions Score 3: 6 to 10 erosions Score 4: > 10 erosions and/or an ulcer

Enrollment: 77
Study Start Date: July 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PL3100 Drug: PL3100
Oral administration
Active Comparator: Naproxen Drug: Naproxen
Oral administration


Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01139190

United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States, 75216
Houston Center For Clinical Research
Houston, Texas, United States, 77074
Sponsors and Collaborators
PLx Pharma
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  More Information

Responsible Party: PLx Pharma Identifier: NCT01139190     History of Changes
Other Study ID Numbers: PL-NAP-002  1RC3AR059535-01 
Study First Received: June 4, 2010
Results First Received: June 22, 2015
Last Updated: March 28, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by PLx Pharma:
NSAID-induced gastroduodenal ulcerations or erosion

Additional relevant MeSH terms:
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on October 26, 2016