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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01139190
Recruitment Status : Completed
First Posted : June 8, 2010
Results First Posted : April 11, 2016
Last Update Posted : April 11, 2016
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
PLx Pharma

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

Condition or disease Intervention/treatment Phase
Gastroduodenal Ulcerations Erosion Drug: PL3100 Drug: Naproxen Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : July 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PL3100 Drug: PL3100
Oral administration

Active Comparator: Naproxen Drug: Naproxen
Oral administration

Primary Outcome Measures :
  1. Degree of GI Injury at Day 15 [ Time Frame: 15 days ]

    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

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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)

Responsible Party: PLx Pharma Identifier: NCT01139190     History of Changes
Other Study ID Numbers: PL-NAP-002
1RC3AR059535-01 ( U.S. NIH Grant/Contract )
First Posted: June 8, 2010    Key Record Dates
Results First Posted: April 11, 2016
Last Update Posted: April 11, 2016
Last Verified: March 2016

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