Gastroduodenal UlcerationPhase 2NCT01646814
Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects
A Phase 2 study testing PL2200 and Aspirin tablets in people with Gastroduodenal Ulceration, run by PLx Pharma at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroduodenal Ulceration
- What is being tested?
- PL2200 and Aspirin tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 10 sitesUnited States
- Study dates
- Sep 2012to Jun 2013
- Phase
- Phase 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
- Healthy volunteers, ≥50 and ≤75 years of age.
- No endoscopically observed baseline gastrointestinal lesions.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Study site
Chesapeake, Virginia
Study site
Dallas, Texas
Study site
High Point, North Carolina
Study site
Houston, Texas
Study site
Jupiter, Florida
Study site
New York, New York
Study site
Raleigh, North Carolina
Study site
San Antonio, Texas
Study site
South Miami, Florida
Study site
Towson, Maryland
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Gastroduodenal Ulceration
- Being tested
- PL2200, Aspirin tablets
- Keywords
- Healthy volunteer, comparison of incidence of, treatment groups.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PL2200Drug
Also called PL-ASA
PL2200, containing 325 mg aspirin active ingredient
Aspirin tabletsDrug
325 mg aspirin tablets (USP)
| Study group | Role | What they receive |
|---|---|---|
| PL2200 | Experimental | Investigational product, PL2200 Receives: Drug: PL2200 |
| Aspirin tablets | Active comparator | Active comparator, 325 mg aspirin tablets Receives: Drug: Aspirin tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Gastroduodenal Ulcers
Cumulative Incidence of Gastroduodenal Ulcers Greater than or equal to 3 mm in length with unequivocal depth
Measured: 42 Days
Secondary outcomes (1)
Number of Subjects With Erosion and Ulcers
>5 erosions or ulcers 3 mm or greater in length with unequivocal depth, by endoscopy
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2013
- Study completionJun 2013
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 Gastroduodenal UlcerationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- PLx Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646814
- Sponsor's protocol ID
- PL-ASA-005
- Status last verified
- May 2022
- First submitted
- 18 Jul 2012
- Last updated
- 7 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded, Endoscopic Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects
- ClinicalTrials.gov ID
- NCT01646814
- Acronym / sponsor ID
- PL-ASA-005
- Conditions
- Gastroduodenal Ulceration
- Keywords
- Healthy volunteer, comparison of incidence of, treatment groups.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- PLx PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Posted 5 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PL2200 | Experimental | Drug: PL2200Investigational product, PL2200 |
| Aspirin tablets | Active comparator | Drug: Aspirin tabletsActive comparator, 325 mg aspirin tablets |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers, ≥50 and ≤75 years of age.
- No endoscopically observed baseline gastrointestinal lesions.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| PL2200Also: PL-ASAPL2200, containing 325 mg aspirin active ingredient | Drug | PL2200 |
| Aspirin tablets325 mg aspirin tablets (USP) | Drug | Aspirin tablets |
Primary outcome
Incidence of Gastroduodenal Ulcers
Time frame: 42 Days
Cumulative Incidence of Gastroduodenal Ulcers Greater than or equal to 3 mm in length with unequivocal depth
1 secondary outcome
Number of Subjects With Erosion and Ulcers
Time frame: 42 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PL2200 and Aspirin tablets in people with Gastroduodenal Ulceration, run by PLx Pharma at 10 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 2 inclusion and 5 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 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 phase mean?
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 5 Oct 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 Gastroduodenal Ulcers (time frame: 42 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2022.