Endoscopic Evaluation of Upper Gastrointestinal (GI) Mucosal Damage Induced by PL-2200 Versus Aspirin in Healthy Volunteers
This study has been completed.
Sponsor:
PLx Pharma
Information provided by:
PLx Pharma
ClinicalTrials.gov Identifier:
NCT00872534
First received: March 10, 2009
Last updated: July 28, 2009
Last verified: May 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
To determine the gastrointestinal safety of PL-2200 versus immediate-release aspirin by assessing endoscopic gastroduodenal mucosal injury at approved daily cardiac-protective doses of aspirin (325 mg) in normal healthy volunteers.
| Condition | Intervention | Phase |
|---|---|---|
|
Upper Gastrointestinal Mucosal Damage |
Drug: acetylsalicylic acid |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | A Randomized, Single-Blind, Endoscopic Evaluation Of Upper GI Mucosal Damage Induced By PL-2200 Versus Aspirin In Healthy Volunteers |
Resource links provided by NLM:
Further study details as provided by PLx Pharma:
Primary Outcome Measures:
- Incidence of subjects with gastroduodenal erosions and ulcers. [ Time Frame: After 7 days of study medication ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of subjects with ulcers (ulcers 3mm or greater in length with unequivocal depth). [ Time Frame: After 7 days of study medication ] [ Designated as safety issue: No ]
- Mean number of erosions in the duodenum and stomach. [ Time Frame: After 7 days of study medication ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 164 |
| Study Start Date: | January 2009 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PL-2200
PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.
|
Drug: acetylsalicylic acid
325mg once a day for 7 days
|
|
Active Comparator: Aspirin
Immediate release 325mg aspirin
|
Drug: acetylsalicylic acid
325mg once a day for 7 days
|
Eligibility| Ages Eligible for Study: | 50 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Subject is ≥50 to ≤75 years of age.
- Subject is healthy.
- Subject has a BMI between 20 and 32
- If female and of child bearing potential, subject has a negative pregnancy test and is not nursing.
Exclusion Criteria:
- Subject has abnormal screening/baseline laboratory parameters or endoscopic observations deemed clinically significant by the Investigator.
- Subject has an active Helicobacter pylori infection.
- Subject has a prior GI ulcer, bleeding, obstruction or perforation.
- Subject has taken aspirin or any aspirin containing product within the last 4 weeks, or a non-aspirin NSAID product within 2 weeks.
- Subject has taken any of the following medications within 2 weeks prior to enrollment: Any anti-platelet agents, anti-coagulants or selective serotonin reuptake inhibitors.
- Subject has used an investigational agent within the past 30 days.
- Subject has hypersensitivity or contraindications to aspirin, ibuprofen, or other NSAID.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872534
Locations
| United States, Florida | |
| Jupiter Research | |
| Jupiter, Florida, United States | |
| Miami Research Associates | |
| South Miami, Florida, United States | |
| United States, Oklahoma | |
| Oklahoma Foundation for Digestive Research | |
| Oklahoma City, Oklahoma, United States | |
| United States, Pennsylvania | |
| Altoona Arthritis and Osteoporosis Center | |
| Altoona, Pennsylvania, United States | |
| United States, Texas | |
| Dallas VA Medical Center | |
| Dallas, Texas, United States | |
| Houston Center For Clinical Research | |
| Houston, Texas, United States | |
Sponsors and Collaborators
PLx Pharma
Investigators
| Principal Investigator: | Byron L Cryer, MD | Dallas VA |
| Principal Investigator: | Frank L Lanza, MD | Houston Institute for Clinical Research |
| Principal Investigator: | Michael E Schwartz, DO | Jupiter Research |
| Principal Investigator: | Alan J Kivitz, MD | Altoona Arthritis and Osteoporosis Center |
| Principal Investigator: | Phillip B Miner, MD | Oklahoma Foundation for Digestive Research |
| Principal Investigator: | Howard Schwartz, MD | Miami Research Associates |
More Information
No publications provided
| Responsible Party: | Upendra Marathi, Senior Vice President, PLx Pharma |
| ClinicalTrials.gov Identifier: | NCT00872534 History of Changes |
| Other Study ID Numbers: | PL-ASA-002 |
| Study First Received: | March 10, 2009 |
| Last Updated: | July 28, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by PLx Pharma:
|
To evaluate the acute gastrointestinal safety of PL-2100. |
Additional relevant MeSH terms:
|
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 June 18, 2013