Gastroduodenal UlcerationsPhase 2NCT01139190

Clinical Trial Evaluating Gastrointestinal Damage Following Administration PL3100 or Naproxen in At-Risk Adults

A Phase 2 study testing PL3100 and Naproxen in people with Gastroduodenal Ulcerations and Erosion, run by PLx Pharma at 2 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

The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of PL3100 versus Naproxen 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: Gastroduodenal Ulcerations, Erosion
What is being tested?: PL3100 and Naproxen
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 77 participants
Where: 2 sitesUnited States
Study dates: Jul 2010to Dec 2010
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

Male and female healthy adult subjects

Who cannot join

Subject has protocol specified significant medical history.
Subject is currently participating, or has participated within 30 days prior to study entry, in an investigational drug study.
Subject has hypersensitivity or contraindications to naproxen, ibuprofen, or other NSAID.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Dallas VA Medical Center
Dallas, Texas, 75216
Houston Center For Clinical Research
Houston, Texas, 77074

Other trials in United States

About this study

Official title: A Phase 2 Clinical Trial Evaluating the Incidence of Upper Gastrointestinal Mucosal Damage Following Administration of Either PL3100 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated GI Damage

The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of PL3100 versus Naproxen in normal healthy volunteers.

Conditions: Gastroduodenal Ulcerations, Erosion
Being tested: PL3100, Naproxen
Keywords: NSAID-induced gastroduodenal ulcerations or erosion

What participants receive

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

PL3100Drug
Oral administration
NaproxenDrug
Oral administration

Study groups in NCT01139190
Study group	Role	What they receive
PL3100	Experimental	Not described Receives: Drug: PL3100
Naproxen	Active comparator	Not described Receives: Drug: Naproxen

What is being measured

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

Degree of GI Injury at Day 15
Degree of mucosal injury was assessed by endoscopy, with the following scoring system:
Score 0: No Injury Score 1: 1 to 10 petechiae Score 2: > 10 petechiae or 1 to 5 erosions Score 3: 6 to 10 erosions Score 4: > 10 erosions and/or an ulcer
Measured: 15 days

Timeline

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

Jul 2010Dec 2010

First posted8 Jun 2010 (estimated)
Study startJul 2010
Primary completionDec 2010
Study completionDec 2010

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 UlcerationsStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01139190
Sponsor's protocol ID: PL-NAP-002
Other IDs: 1RC3AR059535-01
Status last verified: Mar 2016
First submitted: 4 Jun 2010
Last updated: 11 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Gastroduodenal Ulcerations trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Clinical Trial Evaluating the Incidence of Upper Gastrointestinal Mucosal Damage Following Administration of Either PL3100 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated GI Damage
ClinicalTrials.gov ID: NCT01139190
Acronym / sponsor ID: PL-NAP-002
Conditions: Gastroduodenal Ulcerations, Erosion
Keywords: NSAID-induced gastroduodenal ulcerations or erosion
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: PLx PharmaIndustry (pharma, biotech, devices)
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study start: Jul 2010
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 8 Jun 2010 (estimated)
Results: Posted 11 Apr 2016

Clinical summary

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

The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of PL3100 versus Naproxen in normal healthy volunteers.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
PL3100	Experimental	Drug: PL3100
Naproxen	Active comparator	Drug: Naproxen

Who may qualify

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

Key inclusion criteria (1 listed)

Male and female healthy adult subjects

Key exclusion criteria (3 listed)

Subject has protocol specified significant medical history.
Subject is currently participating, or has participated within 30 days prior to study entry, in an investigational drug study.
Subject has hypersensitivity or contraindications to naproxen, ibuprofen, or other NSAID.

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
PL3100Oral administration	Drug	PL3100
NaproxenOral administration	Drug	Naproxen

Primary outcome

Degree of GI Injury at Day 15
Time frame: 15 days
Degree of mucosal injury was assessed by endoscopy, with the following scoring system: Score 0: No Injury Score 1: 1 to 10 petechiae Score 2: > 10 petechiae or 1 to 5 erosions Score 3: 6 to 10 erosions Score 4: > 10 erosions and/or an ulcer

Results and safety

Results posted to the registry on 11 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PL3100	38	38
Naproxen	39	38

Primary outcome: Degree of GI Injury at Day 15

Time frame: 15 days. Number. Unit: participants

Measure	PL3100 n = 34	Naproxen n = 33
Gastroduodenal Score of 3 or Higher	23	20
Gastroduodenal Score of 2 or Less	11	13

Population analysed: Per Protocol Population: subset of participants who had an endoscopy performed at Day 15 reviewed by both blinded endoscopists, was at least 85% compliant with taking the study drug (based on pill counts), who took the final dose drug on the day of the second endoscopy, and who had no other protocol violations that would affect assessments.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PL3100	0 of 38 (0%)	23 of 38 (60.5%)	Not reported
Naproxen	0 of 39 (0%)	7 of 39 (17.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Gastroduodenal Ulcerations

Active, not recruiting
To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children.
Gastritis Chronic, Gastroduodenitis
RecruitingPhase 4
Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy
Coronary Artery Disease, Percutaneous Coronary Intervention
RecruitingObservational study
Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation (STRIDE)
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RecruitingObservational study
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Incarcerated Hernia, Appendicitis Acute
RecruitingPhase 4
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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.

2 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 PL3100 and Naproxen in people with Gastroduodenal Ulcerations and Erosion, run by PLx Pharma at 2 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 1 inclusion and 3 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 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 11 Apr 2016). 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?

Degree of GI Injury at Day 15 (time frame: 15 days). 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 NCT01139190.

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 Apr 2016.