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:
PLx Pharma
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastroduodenal Ulceration |
Drug: PL2200 Drug: Aspirin tablets |
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: Treatment |
Resource links provided by NLM:
Further study details as provided by PLx Pharma:
Primary Outcome Measures:
- Gastroduodenal ulcer incidence [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 220 |
| Study Start Date: | August 2012 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PL2200
Investigational product, PL2200
|
Drug: PL2200
PL2200, containing 325 mg aspirin active ingredient
|
|
Active Comparator: Aspirin tablets
Active comparator, 325 mg aspirin tablets
|
Drug: Aspirin tablets
325 mg aspirin tablets (USP)
|
Eligibility| Ages Eligible for Study: | 50 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646814
Contacts
| Contact: Hannah Hayes | 502.690.8567 | HHayes@parabio.com |
Locations
| United States, Florida | |
| Recruiting | |
| Jupiter, Florida, United States | |
| Contact: Upendra Marathi, PhD 713-842-1249 ext 202 PLASA005@plxpharma.com | |
| Recruiting | |
| South Miami, Florida, United States | |
| Contact: Upendra Marathi, PhD 713-842-1249 ext 202 PLASA005@plxpharma.com | |
| United States, Maryland | |
| Recruiting | |
| Towson, Maryland, United States | |
| Contact: Upendra Marathi, PhD 713-842-1249 ext 202 PLASA005@plxpharma.com | |
| United States, New York | |
| Recruiting | |
| New York, New York, United States | |
| Contact: Upendra Marathi, PhD 713-842-1249 ext 202 PLASA005@plxpharma.com | |
| United States, North Carolina | |
| Recruiting | |
| High Point, North Carolina, United States | |
| Contact: Upendra Marathi, PhD 713-842-1249 ext 202 PLASA005@plxpharma.com | |
| Recruiting | |
| Raleigh, North Carolina, United States | |
| Contact: Upendra Marathi, PhD 713-842-1249 ext 202 PLASA005@plxpharma.com | |
| United States, Texas | |
| Recruiting | |
| Dallas, Texas, United States | |
| Contact: Upendra Marathi, PhD 713-842-1249 ext 202 PLASA005@plxpharma.com | |
| Recruiting | |
| Houston, Texas, United States | |
| Contact: Upendra Marathi, PhD 713-842-1249 ext 202 PLASA005@plxpharma.com | |
| Recruiting | |
| San Antonio, Texas, United States | |
| Contact: Upendra Marathi, PhD 713-842-1249 ext 202 PLASA005@plxpharma.com | |
| United States, Virginia | |
| Recruiting | |
| Cheseapeake, Virginia, United States | |
| Contact: Upendra Marathi, PhD 713-842-1249 ext 202 PLASA005@plxpharma.com | |
Sponsors and Collaborators
PLx Pharma
More Information
No publications provided
| Responsible Party: | PLx Pharma |
| ClinicalTrials.gov Identifier: | NCT01646814 History of Changes |
| Other Study ID Numbers: | PL-ASA-005 |
| Study First Received: | July 18, 2012 |
| Last Updated: | October 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by PLx Pharma:
|
Healthy volunteer comparison of incidence of treatment groups. |
Additional relevant MeSH terms:
|
Ulcer Pathologic Processes Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses |
Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013