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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
Results First Received: June 22, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Gastroduodenal Ulcerations
Erosion
Interventions: Drug: PL3100
Drug: Naproxen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment initiated: 01 July 2010, Multicenter trial: Private practice setting and Veterans Administration gastroenterology clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No run-in period; subjects screened and enrolled based on review and confirmation of eligibility per inclusion/exclusion criteria. Wash-out period for NSAIDs and gastroprotective agents.

Reporting Groups
  Description
PL3100 Subjects were to take 500 mg of PL3100 (two 250 mg capsules) of study drug twice a day for a total duration of 14.5 days.
Naproxen Subjects were to take 500 mg of Naproxen (two 250 mg tablets) of study drug twice a day for a total duration of 14.5 days.

Participant Flow:   Overall Study
    PL3100     Naproxen  
STARTED     38     39  
COMPLETED     38     38  
NOT COMPLETED     0     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PL3100 Subjects were to take 500 mg of PL3100 (two 250 mg capsules) of study drug twice a day for a total duration of 14.5 days.
Naproxen Subjects were to take 500 mg of Naproxen (two 250 mg tablets) of study drug twice a day for a total duration of 14.5 days.
Total Total of all reporting groups

Baseline Measures
    PL3100     Naproxen     Total  
Number of Participants  
[units: participants]
  38     39     77  
Age  
[units: years]
Mean (Standard Deviation)
  56.7  (5.97)     55.6  (4.56)     56.1  (5.29)  
Gender  
[units: participants]
     
Female     22     20     42  
Male     16     19     35  



  Outcome Measures

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ronald Zimmerman, CEO & President
Organization: PLx Pharma LLC
phone: 713-842-1249 ext 205
e-mail: ron.zimmerman@plxpharma.com



Responsible Party: PLx Pharma
ClinicalTrials.gov Identifier: NCT01139190     History of Changes
Other Study ID Numbers: PL-NAP-002
1RC3AR059535-01 ( US NIH Grant/Contract Award Number )
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