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: August 18, 2014
Last verified: August 2014

July 18, 2012
August 18, 2014
September 2012
June 2013   (final data collection date for primary outcome measure)
Gastroduodenal ulcer incidence [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Ulcer incidence [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01646814 on ClinicalTrials.gov Archive Site
Not Provided
Ulcer incidence [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects
A Randomized, Blinded, Endoscopic Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects

This trial is a Phase 2, randomized, controlled study to compare the degree of mucosal injury after the oral administration of an investigational product, PL2200, and a marketed 325 mg immediate-release aspirin product. Each group will be treated with either an immediate-release aspirin tablet or PL2200 capsule at 325 mg per day for 6 weeks, and evaluated via an endoscope for any gastrointestinal injury that may have been caused by study medication.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Gastroduodenal Ulceration
  • Drug: PL2200
    PL2200, containing 325 mg aspirin active ingredient
  • Drug: Aspirin tablets
    325 mg aspirin tablets (USP)
  • Experimental: PL2200
    Investigational product, PL2200
    Intervention: Drug: PL2200
  • Active Comparator: Aspirin tablets
    Active comparator, 325 mg aspirin tablets
    Intervention: Drug: Aspirin tablets
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
247
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteers, ≥50 and ≤75 years of age.
  • No endoscopically observed baseline gastrointestinal lesions.

Exclusion Criteria:

  • Baseline gastrointestinal lesions or abnormal screening/baseline laboratory parameters deemed clinically significant by the Investigator.
  • Significant history of substance abuse or uncontrolled acute or chronic medical illness.
  • Active H. pylori infection.
  • Current use of low-dose aspirin for cardioprevention, or other ulcerogenic medications, gastroprotective, or anti-platelet agents.
  • Hypersensitivity to aspirin or other NSAIDs.
Both
50 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01646814
PL-ASA-005
Yes
PLx Pharma
PLx Pharma
Not Provided
Not Provided
PLx Pharma
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP