Upper Gastrointestinal Mucosal DamagePhase 1/2NCT00872534

Endoscopic Evaluation of Upper Gastrointestinal (GI) Mucosal Damage Induced by PL-2200 Versus Aspirin in Healthy Volunteers

A Phase 1/2 study testing acetylsalicylic acid in people with Upper Gastrointestinal Mucosal Damage, run by PLx Pharma at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 50 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Upper Gastrointestinal Mucosal Damage
What is being tested?: acetylsalicylic acid
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 204 participants
Where: 6 sitesUnited States
Study dates: Jan 2009to Jul 2009
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Altoona Arthritis and Osteoporosis Center
Altoona, Pennsylvania
Dallas VA Medical Center
Dallas, Texas
Houston Center For Clinical Research
Houston, Texas
Jupiter Research
Jupiter, Florida
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma
Miami Research Associates
South Miami, Florida

Other trials in United States

About this study

Official title: A Randomized, Single-Blind, Endoscopic Evaluation Of Upper GI Mucosal Damage Induced By PL-2200 Versus Aspirin In Healthy Volunteers

Conditions: Upper Gastrointestinal Mucosal Damage
Being tested: acetylsalicylic acid
Keywords: To evaluate the acute gastrointestinal safety of PL-2100.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

acetylsalicylic acidDrug
325mg once a day for 7 days

Study groups in NCT00872534
Study group	Role	What they receive
PL-2200	Experimental	PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix. Receives: Drug: acetylsalicylic acid
Aspirin	Active comparator	Immediate release 325mg aspirin Receives: Drug: acetylsalicylic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Subjects With Gastroduodenal Erosions and Ulcers.
Incidence of subjects with gastroduodenal composite scores of 3 or 4 (> 5 erosions or 1 or more ulcers 3 mm or greater in length with unequivocal depth).
Measured: After 7 days of study medication

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Jul 2009

First posted31 Mar 2009 (estimated)
Study startJan 2009
Primary completionJul 2009
Study completionJul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Upper Gastrointestinal Mucosal DamageStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 204 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00872534
Sponsor's protocol ID: PL-ASA-002
Status last verified: Aug 2015
First submitted: 10 Mar 2009
Last updated: 11 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Single-Blind, Endoscopic Evaluation Of Upper GI Mucosal Damage Induced By PL-2200 Versus Aspirin In Healthy Volunteers
ClinicalTrials.gov ID: NCT00872534
Acronym / sponsor ID: PL-ASA-002
Conditions: Upper Gastrointestinal Mucosal Damage
Keywords: To evaluate the acute gastrointestinal safety of PL-2100.
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 204 participants (actual)
Lead sponsor: PLx PharmaIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 31 Mar 2009 (estimated)
Results: Posted 11 Aug 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
PL-2200	Experimental	Drug: acetylsalicylic acidPL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.
Aspirin	Active comparator	Drug: acetylsalicylic acidImmediate release 325mg aspirin

Who may qualify

Ages: 50 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
acetylsalicylic acid325mg once a day for 7 days	Drug	Aspirin, PL-2200

Primary outcome

Incidence of Subjects With Gastroduodenal Erosions and Ulcers.
Time frame: After 7 days of study medication
Incidence of subjects with gastroduodenal composite scores of 3 or 4 (> 5 erosions or 1 or more ulcers 3 mm or greater in length with unequivocal depth).

Results and safety

Results posted to the registry on 11 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PL-2200	100	97
Aspirin	104	101

Primary outcome: Incidence of Subjects With Gastroduodenal Erosions and Ulcers.

Time frame: After 7 days of study medication. Number. Unit: participants

Measure	PL-2200 n = 91	Aspirin n = 90
Gastroduodenal Composite Score of 3 or 4 (NO)	72	54
Gastroduodenal Composite Score of 3 or 4 (YES)	19	36

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PL-2200	0 of 100 (0%)	8 of 100 (8%)	Not reported
Aspirin	0 of 104 (0%)	14 of 104 (13.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Byron L Cryer, MD principal investigator

Dallas VA

Frank L Lanza, MD principal investigator

Houston Institute for Clinical Research

Michael E Schwartz, DO principal investigator

Jupiter Research

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing acetylsalicylic acid in people with Upper Gastrointestinal Mucosal Damage, run by PLx Pharma at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Subjects With Gastroduodenal Erosions and Ulcers. (time frame: After 7 days of study medication). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00872534.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2015.