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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
PLx Pharma
ClinicalTrials.gov Identifier:
NCT01139190
First received: June 4, 2010
Last updated: March 28, 2016
Last verified: March 2016
  Purpose
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
Erosion
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

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139190

Locations
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
ClinicalTrials.gov 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:
Ulcer
Pathologic Processes
Naproxen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 05, 2016