Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PLx Pharma
ClinicalTrials.gov Identifier:
NCT01646814
First received: July 18, 2012
Last updated: September 3, 2015
Last verified: September 2015
Results First Received: June 18, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Gastroduodenal Ulceration
Interventions: Drug: PL2200
Drug: Aspirin tablets

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PL2200

Investigational product, PL2200

PL2200: PL2200, containing 325 mg aspirin active ingredient

Aspirin Tablets

Active comparator, 325 mg aspirin tablets

Aspirin tablets: 325 mg aspirin tablets (USP)


Participant Flow:   Overall Study
    PL2200     Aspirin Tablets  
STARTED     121     126  
COMPLETED     110     120  
NOT COMPLETED     11     6  



  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.
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Reporting Groups
  Description
PL2200

Investigational product, PL2200

PL2200: PL2200, containing 325 mg aspirin active ingredient

Aspirin Tablets

Active comparator, 325 mg aspirin tablets

Aspirin tablets: 325 mg aspirin tablets (USP)

Total Total of all reporting groups

Baseline Measures
    PL2200     Aspirin Tablets     Total  
Number of Participants  
[units: participants]
  121     126     247  
Age, Customized  
[units: participants]
     
≥ 50 and ≤ 75 years     121     126     247  
Gender  
[units: participants]
     
Female     71     82     153  
Male     50     44     94  



  Outcome Measures

1.  Primary:   Incidence of Gastroduodenal Ulcers   [ Time Frame: 42 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 less than or equal to 60 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: Regulatory Affairs Director
Organization: PLxPharma
phone: 17138421249
e-mail: regaffairs@plxpharma.com



Responsible Party: PLx Pharma
ClinicalTrials.gov Identifier: NCT01646814     History of Changes
Other Study ID Numbers: PL-ASA-005
Study First Received: July 18, 2012
Results First Received: June 18, 2015
Last Updated: September 3, 2015
Health Authority: United States: Food and Drug Administration