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

This study is currently recruiting participants.

Verified October 2012 by PLx Pharma

Sponsor:

Information provided by (Responsible Party):

PLx Pharma

ClinicalTrials.gov Identifier:

NCT01646814

First received: July 18, 2012

Last updated: October 2, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 18, 2012

Last Updated Date

October 2, 2012

Start Date ^ICMJE

August 2012

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Gastroduodenal ulcer incidence [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Ulcer incidence [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT01646814 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Ulcer incidence [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Gastroduodenal Ulceration

Intervention ^ICMJE

Drug: PL2200
PL2200, containing 325 mg aspirin active ingredient
Drug: Aspirin tablets
325 mg aspirin tablets (USP)

Study Arm (s)

Experimental: PL2200
Investigational product, PL2200

Intervention: Drug: PL2200
Active Comparator: Aspirin tablets
Active comparator, 325 mg aspirin tablets

Intervention: Drug: Aspirin tablets

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

220

Completion Date

Not Provided

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

50 Years to 75 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Hannah Hayes

502.690.8567

HHayes@parabio.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01646814

Other Study ID Numbers ^ICMJE

PL-ASA-005

Has Data Monitoring Committee

Yes

Responsible Party

PLx Pharma

Study Sponsor ^ICMJE

PLx Pharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

PLx Pharma

Verification Date

October 2012

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

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