ClinicalTrials.gg
CompletedNCT03318783SUSHIUpdated Jan 22, 2021Results posted

Subarachnoid Hemorrhage and Soluble Epoxide Hydrolase Inhibition Trial

A Phase 1/2 interventional study of GSK2256294 and Placebo in Subarachnoid Hemorrhage, Aneurysmal, Delayed Cerebral Ischemia and Vasospasm, Cerebral, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-22.

Sponsored by Oregon Health and Science University · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 149 studies in Subarachnoid Hemorrhage with a site in United States — 31 open to participants now, 37 under way, 2 of them phase 3. Subarachnoid Hemorrhage · United States.

Enrollment
64th of 107
20 · median 30
Started
2018
with 8 others
Phase 1/2
13 of 149
1 open now
Registered
89th of 149
by date

Among the 149 studies in Subarachnoid Hemorrhage with a site in United States, this one is the 64th largest by enrollment of the 107 interventional ones that give a count, is one of 9 that started in 2018, is one of 13 in phase 1/2, and was the 89th registered.

Subarachnoid Hemorrhage

510 studies on the registry are indexed under Subarachnoid Hemorrhage; 128 are open to participants now.

Browse Subarachnoid Hemorrhage studies →

Open to participants now

31 of the 149 studies in Subarachnoid Hemorrhage with a site in United States are open now. Recruiting first, the newest first:

26 more — sign in →

All 31 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 89 Subarachnoid Hemorrhage studies recruiting now, 56 (63%) set no upper age limit and 4 (4%) stop at 75 or younger; 7 take children under 18; 7 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 149 studies in Subarachnoid Hemorrhage with a site in United States, or all of them as a file.
02

Study summary

Soluble epoxide hydrolase (sEH) is the metabolizing enzyme of epoxyeicosatrienoic acids (EETs), which may play a role in reducing neuroinflammation and regulating cerebral blood flow after subarachnoid hemorrhage (SAH). Hypotheses: Pharmacologic inhibition of the sEH enzyme is safe and will result in increased EETs availability in the blood and cerebrospinal fluid. This study is a double-blind, placebo-controlled, phase 1b randomized trial to evaluate the safety and efficacy of GSK2256294, a novel soluble epoxide hydrolase inhibitor in patients with aneurysmal SAH.

Read the detailed description

Study Description: Soluble epoxide hydrolase (sEH) is the metabolizing enzyme of epoxyeicosatrienoic acids (EETs), which may play a role in reducing neuroinflammation and regulating cerebral blood flow after subarachnoid hemorrhage (SAH).

Hypothesis: Pharmacologic inhibition of the sEH enzyme is safe and will result in increased EETs availability at the neurovascular unit, and a measured increase in the EET/DHET ratio in the serum and cerebrospinal fluid. This study is a double-blind, placebo-controlled, phase 1b randomized trial to evaluate the safety and of GSK2256294, an inhibitor of soluble epoxide hydrolase, in patients with aneurysmal SAH.

Objectives:

Primary Objective:

Determine the safety of administration of GSK2256294 in patients with aneurysmal SAH.

Secondary Objective:

Determine the pharmacodynamic effect of administration of GSK2256294 in patients with aneurysmal SAH on reducing EETs metabolism and biomarkers of cerebrovascular inflammation and endothelial injury.

Tertiary Objective:

Provide preliminary estimates of clinical endpoints to inform the design of a larger trial

Endpoints:

Primary Endpoints:

Determination of safety

Secondary endpoints:

  1. Study days 7 and 10 serum EET/DHET ratios
  2. Study days 7 and 10 cerebrospinal fluid (CSF) EET/DHET ratios
  3. Study days 7 and 10 serum EPOME/DPOME ratio
  4. Neuroinflammatory and endothelial injury biomarker levels from the blood and CSF at day 7 and day 10.

Tertiary, exploratory endpoints:

Clinical outcomes associated with SAH including neurologic status, disposition, vital status and incidence of delayed cerebral ischemia.

20 subjects will be randomized. Patients age 18 or above with confirmed ruptured aneurysms will be approached to provide written informed consent

Phase: Phase 1B

Description of Sites/Facilities Enrolling Participants: The study will take place at Oregon Health \& Science University Hospital, with enrollment of patients admitted to the OHSU NSICU, a part of a comprehensive stroke center certified by the American Heart Association and Joint Commission for Accreditation of Healthcare Organizations, with a catchment area including the state of Oregon, Southwest Washington and Northern California. Approximately 80-100 patients with aneurysmal SAH are admitted each year.

Description of Study Intervention: Twenty patients will be equally randomized to receive once daily either 10 mg dose of GSK2256294 or placebo enterally for a duration of 10 days.

Study Duration: 24 months

Participant Duration: 90 days

03

Conditions studied

  • Subarachnoid Hemorrhage, Aneurysmal
  • Delayed Cerebral Ischemia
  • Vasospasm, Cerebral
  • Endothelial Dysfunction

Keywords

  • Eicosanoids
  • Epoxyeicosatrienoic Acids
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age > 18
  2. Head CT evidence of subarachnoid hemorrhage
  3. Digital subtraction cerebral angiography or CT angiogram documenting the presence of a cerebral aneurysm.

Exclusion criteria

Exclusion Criteria:

  1. Symptom onset compatible with SAH of > 3 days prior to admission to OHSU
  2. Absence of an indwelling external ventricular drain
  3. Administration of any of the following inducers/inhibitors of : ritonavir, indinavir, nelfinavir, saquinavir, clarithromycin, telithromycin, chloramphenicol, ketoconazole, itraconazole, nefazodone, cobicistat or enzalutamide.
  4. Suspected or confirmed pregnancy
  5. Preexisting severe neurologic deficit or condition
  6. Chronic renal failure requiring dialysis
  7. Severe terminal disease with \<6 months
  8. Unable to read or understand written or spoken English or Spanish
  9. Refusal of
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    GSK2256294

    10mg capsules of GSK2256294 will be administered in a single dose once daily enterally for a duration of 10 days.

    Drug: GSK2256294

  • Placebo comparator
    Placebo

    10mg matched placebo capsules will be administered in a single dose once daily enterally for a duration of 10 days.

    Drug: Placebo

Interventions

  • GSK2256294 will be administered in a single dose once daily enteral for a duration of 10 days.

  • DrugPlacebo

    Placebo will be administered in a single dose once daily enteral for a duration of 10 days.

06

What researchers measure

Primary outcomes

  1. Participants With Adverse Events

    Summary tables and listings will be provided for all reported adverse events, defined as adverse events that start on or after the first administration of study drug. The reported adverse event term will be assigned a standardized preferred term. Adverse events will be summarized based on the number and percentage of patients experiencing the event. In the event a patient experiences repeat episodes of the same adverse event, then the event with the highest severity grade and strongest causal relationship to study treatment will be used for purposes of incidence tabulations. All deaths will be reported in a patient listing, which will include the primary cause of death and the number of days between the date of the last dose of study drug and death.

    Time frame: 90 days

Secondary outcomes

  1. Study Day 7 and Study Day 10 Serum and CSF EET/ Dihyroxyeicosatrienoic (DHET) Ratio, by Mass Spectroscopic Analysis (ng/mL)

    Day 7 and day 10 serum EET/DHET ratios will be measured by liquid chromatography and mass spectroscopy of collected blood samples. Day 7 and day 10 CSF EET/DHET ratios will be measured by liquid chromatography and mass spectroscopy of collected CSF samples.

    Time frame: 10 days

  2. Study Day 7 and Study Day 10 Serum Epoxyoctadecenoic Acid (EPOME) to Dihydroxyoctadec-12-enoic Acid (DPOME) Ratio, by Mass Spectroscopic Analysis (ng/mL)

    Study day 7 and study day 10 serum epoxyoctadecenoic acid (EPOME) to dihydroxyoctadec-12-enoic acid (DPOME) ratio, will be measure by mass spectroscopic analysis of collected blood samples.

    Time frame: 10 days

  3. Serum Biomarkers of Endothelial Injury From Blood Samples Obtained on Study Day 7 and Study Day 10

    The following serum biomarkers will be obtained from collected blood samples by Luminex assay: e-selectin, p-selectin, Vascular cell adhesion marker (VCAM-1), Platelet endothelial cell adhesion marker (PECAM-1, CD31), intercellular adhesion molecule (ICAM-1).

    Time frame: 10 days

  4. CSF Biomarkers of Neuroinflammation, From Blood Samples Obtained on Study Day 7 and Study Day 10

    The following CSF biomarker will be obtained from collected CSF samples by Luminex assay: Tumor necrosis factor alpha (TNF-α) (pg/mL), Interleukin 1β (IL-1β) (pg/mL), Interferon gamma (IFN-γ) (pg/mL), Interleukin 6 (IL-6) (pg/mL), Interleukin 8 (IL-8) (pg/mL), Monocyte chemoattractant protein 1 (MCP-1) (pg/mL)

    Time frame: 10 days

Other outcomes

  1. Hospital Length of Stay in Days

    The hospital length of stay will be recorded in days, at the time of hospital discharge.

    Time frame: 90 days

  2. Discharge Disposition

    The disposition from the hospital in one of the following categories: home, home with services, rehab, long term acute care facility, skilled nursing facility, hospice, death

    Time frame: 90 days

  3. Number of Participants With New Stroke on Hospital Discharge Imaging

    The last head CT or other brain imaging to detect the presence of a new area of cerebral infarction will be reviewed at the time of hospital discharge. A cerebral infarction will be defined as a one identified on hospital discharge that was not present on imaging between 24-48 hours after aneurysm occlusion, and not attributable to other causes such as surgical clipping or endovascular treatment. Hypodensities resulting from extraventricular drains or residual intraparencyhmal hematomas will not be considered new strokes.

    Time frame: 90 days

  4. Modified Rankin Scale (mRS) at Hospital Discharge and 90 Day Follow up

    The mRS score will be determined by patient or surrogate interview, at both hospital discharge and 90 day follow up. Scores will be assigned based on the following: 0 - no symptoms, 1 - no significant disability, able to carry out all usual activities despite some symptoms, 2 - slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 - moderate disability, requires some help, but able to walk unassisted, 4 - moderately severe disability, unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 - severe disability, requires constant nursing care and attention, bedridden, incontinent, 6 - deceased.

    Time frame: 90 days

  5. Extended Glasgow Outcome Scale (GOSE) Score at 90 Day Follow up

    At 90 day follow up, the GOSE will be determined by patient or surrogate telephone interview, based on a structured interview of 19 questions. The GOSE is a scale of 1-8 where 1 - deceased, 2 - vegetative state, 3 - low severe disability, 4 - upper severe disability, 5 - low moderate disability, 6 -upper moderate disability, 7 - low good recovery, 8 - upper good recovery.

    Time frame: 90 days

07

Results

Posted Jan 22, 2021

Participant flow

Participant flow — Overall Study
MilestoneGSK2256294Placebo
Started1010
Completed108
Not completed02
Withdrew: Withdrawal by subject01
Withdrew: Death01

Outcome measures

PrimaryParticipants With Adverse Events

Summary tables and listings will be provided for all reported adverse events, defined as adverse events that start on or after the first administration of study drug. The reported adverse event term will be assigned a standardized preferred term. Adverse events will be summarized based on the number and percentage of patients experiencing the event. In the event a patient experiences repeat episodes of the same adverse event, then the event with the highest severity grade and strongest causal relationship to study treatment will be used for purposes of incidence tabulations. All deaths will be reported in a patient listing, which will include the primary cause of death and the number of days between the date of the last dose of study drug and death.

Time frame:
90 days
Reported as:
Count of participants · Participants
Participants With Adverse Events
ParticipantsGSK2256294Placebo
Venous Thromboembolism20
Myocardial Infarction00
Seizure11
Any Documented Infection46
Cerebral Salt Wasting32
Leukopenia01
Aneurysm Rebleed01
Acute Respiratory Distress Syndrome01
Death01
SecondaryStudy Day 7 and Study Day 10 Serum and CSF EET/ Dihyroxyeicosatrienoic (DHET) Ratio, by Mass Spectroscopic Analysis (ng/mL)

Day 7 and day 10 serum EET/DHET ratios will be measured by liquid chromatography and mass spectroscopy of collected blood samples. Day 7 and day 10 CSF EET/DHET ratios will be measured by liquid chromatography and mass spectroscopy of collected CSF samples.

Time frame:
10 days
Reported as:
Mean · ration
Study Day 7 and Study Day 10 Serum and CSF EET/ Dihyroxyeicosatrienoic (DHET) Ratio, by Mass Spectroscopic Analysis (ng/mL)
rationGSK2256294Placebo
Study day 7 CSF 14,15-EET/DHET ratio.17 ± .07.19 ± .16
Study day 10 CSF 14,15-EET/DHET ratio.45 ± .78.52 ± 1.04
Study day 7 serum 14,15-EET/DHET ratio.30 ± .11.12 ± .03
Study day 10 serum 14,15-EET/DHET ratio.27 ± .07.12 ± .02
SecondaryStudy Day 7 and Study Day 10 Serum Epoxyoctadecenoic Acid (EPOME) to Dihydroxyoctadec-12-enoic Acid (DPOME) Ratio, by Mass Spectroscopic Analysis (ng/mL)

Study day 7 and study day 10 serum epoxyoctadecenoic acid (EPOME) to dihydroxyoctadec-12-enoic acid (DPOME) ratio, will be measure by mass spectroscopic analysis of collected blood samples.

Time frame:
10 days
Reported as:
Mean · ration
Study Day 7 and Study Day 10 Serum Epoxyoctadecenoic Acid (EPOME) to Dihydroxyoctadec-12-enoic Acid (DPOME) Ratio, by Mass Spectroscopic Analysis (ng/mL)
rationGSK2256294Placebo
Day 7 serum 12,13 EpOME/DiHOME ratio6.0 ± 4.31.8 ± .92
Day 10 serum 12,13 EpOME/DiHOME ratio8.7 ± 7.11.7 ± .90
SecondarySerum Biomarkers of Endothelial Injury From Blood Samples Obtained on Study Day 7 and Study Day 10

The following serum biomarkers will be obtained from collected blood samples by Luminex assay: e-selectin, p-selectin, Vascular cell adhesion marker (VCAM-1), Platelet endothelial cell adhesion marker (PECAM-1, CD31), intercellular adhesion molecule (ICAM-1).

Time frame:
10 days
Reported as:
Mean · ng/mL
Serum Biomarkers of Endothelial Injury From Blood Samples Obtained on Study Day 7 and Study Day 10
ng/mLGSK2256294Placebo
Serum Day 7 ICAM8.4 ± 7.58.3 ± 6.8
Serum Day 10 ICAM17.8 ± 276.7 ± 6.6
Serum Day 7 VCAM8.3 ± 3.07.9 ± 2.0
Serum Day 10 VCAM8.9 ± 2.97.9 ± 2.1
Serum Day 7 PECAM-11.4 ± .561.7 ± .90
Serum Day 10 PECAM-11.7 ± .901.6 ± .65
Serum Day 7 E-Selectin46.6 ± 25.348.0 ± 33.0
Serum Day 10 E-Selectin53.0 ± 23.844.7 ± 30.3
Serum Day 7 P-Selectin1.4 ± .831.1 ± .28
Serum Day 10 P-Selectin1.7 ± .902.0 ± 2.2
SecondaryCSF Biomarkers of Neuroinflammation, From Blood Samples Obtained on Study Day 7 and Study Day 10

The following CSF biomarker will be obtained from collected CSF samples by Luminex assay: Tumor necrosis factor alpha (TNF-α) (pg/mL), Interleukin 1β (IL-1β) (pg/mL), Interferon gamma (IFN-γ) (pg/mL), Interleukin 6 (IL-6) (pg/mL), Interleukin 8 (IL-8) (pg/mL), Monocyte chemoattractant protein 1 (MCP-1) (pg/mL)

Time frame:
10 days
Reported as:
Mean · pg / mL
CSF Biomarkers of Neuroinflammation, From Blood Samples Obtained on Study Day 7 and Study Day 10
pg / mLGSK2256294Placebo
CSF Day 7 IFN-gamma1.9 ± 1.04.6 ± 6.8
CSF Day 10 IFN-gamma1.5 ± .845.8 ± 12.9
CSF Day 7 IL-1b1.6 ± .825.0 ± 9.6
CSF Day 10 IL-1b1.0 ± .504.4 ± 9.2
CSF Day 7 IL-62991.2 ± 3420.03417.9 ± 4110.2
CSF Day 10 IL-62089.4 ± 3248.42051.6 ± 3570.7
CSF Day 7 IL-81652.4 ± 1374.43971.0 ± 3298.9
CSF Day 10 IL-81093.6 ± 775.31485.8 ± 1002.2
CSF Day 7 TNF-alpha7.8 ± 2.613.1 ± 15.6
CSF Day 10 TNF-alpha5.9 ± 2.88.1 ± 9.9
Other pre-specifiedHospital Length of Stay in Days

The hospital length of stay will be recorded in days, at the time of hospital discharge.

Time frame:
90 days
Reported as:
Mean · days
Hospital Length of Stay in Days
daysGSK2256294Placebo
Hospital Length of Stay in Days16.9 ± 3.328.8 ± 19.8
Other pre-specifiedDischarge Disposition

The disposition from the hospital in one of the following categories: home, home with services, rehab, long term acute care facility, skilled nursing facility, hospice, death

Time frame:
90 days
Reported as:
Count of participants · Participants
Discharge Disposition
ParticipantsGSK2256294Placebo
Discharged to home72
Discharged to rehab, long term acute care facility, skilled nursing facility, hospice, death37
Other pre-specifiedNumber of Participants With New Stroke on Hospital Discharge Imaging

The last head CT or other brain imaging to detect the presence of a new area of cerebral infarction will be reviewed at the time of hospital discharge. A cerebral infarction will be defined as a one identified on hospital discharge that was not present on imaging between 24-48 hours after aneurysm occlusion, and not attributable to other causes such as surgical clipping or endovascular treatment. Hypodensities resulting from extraventricular drains or residual intraparencyhmal hematomas will not be considered new strokes.

Time frame:
90 days
Reported as:
Count of participants · Participants
Number of Participants With New Stroke on Hospital Discharge Imaging
ParticipantsGSK2256294Placebo
Number of Participants With New Stroke on Hospital Discharge Imaging11
Other pre-specifiedModified Rankin Scale (mRS) at Hospital Discharge and 90 Day Follow up

The mRS score will be determined by patient or surrogate interview, at both hospital discharge and 90 day follow up. Scores will be assigned based on the following: 0 - no symptoms, 1 - no significant disability, able to carry out all usual activities despite some symptoms, 2 - slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 - moderate disability, requires some help, but able to walk unassisted, 4 - moderately severe disability, unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 - severe disability, requires constant nursing care and attention, bedridden, incontinent, 6 - deceased.

Time frame:
90 days
Reported as:
Mean · units on a scale
Modified Rankin Scale (mRS) at Hospital Discharge and 90 Day Follow up
units on a scaleGSK2256294Placebo
Hospital Discharge mRS3.4 ± 1.54.1 ± 1.4
90 day follow-up mRS2.2 ± 1.63.3 ± 1.7
Other pre-specifiedExtended Glasgow Outcome Scale (GOSE) Score at 90 Day Follow up

At 90 day follow up, the GOSE will be determined by patient or surrogate telephone interview, based on a structured interview of 19 questions. The GOSE is a scale of 1-8 where 1 - deceased, 2 - vegetative state, 3 - low severe disability, 4 - upper severe disability, 5 - low moderate disability, 6 -upper moderate disability, 7 - low good recovery, 8 - upper good recovery.

Time frame:
90 days
Reported as:
Mean · score on a scale
Extended Glasgow Outcome Scale (GOSE) Score at 90 Day Follow up
score on a scaleGSK2256294Placebo
Extended Glasgow Outcome Scale (GOSE) Score at 90 Day Follow up5.4 ± 2.44.1 ± 2.4

Adverse events

Collected over Adverse event data was collected up to 90 days after hospital discharge at the time of followup phone visit. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
GSK22562940/10 (0%)4/10 (40%)0/10 (0%)
Placebo1/9 (11.1%)5/9 (55.6%)0/10 (0%)
Most frequent serious events
Most frequent serious events
EventGSK2256294Placebo
Urinary Tract InfectionInfections and infestations1/102/9
Delayed Cerebral IschemiaNervous system disorders2/101/9
Deep Vein ThrombosisBlood and lymphatic system disorders2/100/9
Rebleed of Unsecured AneurysmNervous system disorders0/101/9
Aspiration PneumoniaInfections and infestations1/101/9
LeukopeniaBlood and lymphatic system disorders0/101/9
Acute Respiratory Distress SyndromeRespiratory, thoracic and mediastinal disorders0/101/9
Pseudomonas Ventriculitis, Bacteremia, Urinary Tract InfectionInfections and infestations0/101/9
Central Line Associated Bloodstream InfectionInfections and infestations1/100/9

Baseline characteristics

1 subject in the placebo group died on study day 9 after having received 9 of 10 doses of study drug. Data is included for this subject throughout the analysis

Age, Continuous
Age, Continuous(years)GSK2256294PlaceboTotal
Mean61.2 ± 11.260.4 ± 11.460.8 ± 11.1
Sex: Female, Male
Sex: Female, Male(Participants)GSK2256294PlaceboTotal
Female6612
Male437
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)GSK2256294PlaceboTotal
Hispanic or Latino022
Not Hispanic or Latino10717
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)GSK2256294PlaceboTotal
American Indian or Alaska Native000
Asian202
Native Hawaiian or Other Pacific Islander000
Black or African American000
White8816
More than one race000
Unknown or Not Reported011
Region of Enrollment
Region of Enrollment(participants)GSK2256294PlaceboTotal
United States10919
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)GSK2256294PlaceboTotal
Mean28.8 ± 6.627.7 ± 4.728.2 ± 5.6
Smoking
Smoking(Participants)GSK2256294PlaceboTotal
Never/Passive Smoker257
Active Smoker538
Former Smoker314
History of Hypertension
History of Hypertension(Participants)GSK2256294PlaceboTotal
Count of participants6915

16 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
09

References and documents

Publications

  • Martini RP, Siler D, Cetas J, Alkayed NJ, Allen E, Treggiari MM. A Double-Blind, Randomized, Placebo-Controlled Trial of Soluble Epoxide Hydrolase Inhibition in Patients with Aneurysmal Subarachnoid Hemorrhage. Neurocrit Care. 2022 Jun;36(3):905-915. doi: 10.1007/s12028-021-01398-8. Epub 2021 Dec 6. PubMed 34873674 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2018 to primary completion in Apr 2019, 11 months.

Results were first posted in Jan 2021, 1 year 9 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 10, 2017
First posted
Oct 24, 2017
StartActual
May 2, 2018
Primary completionActual
Apr 3, 2019
CompletionActual
Jan 9, 2020
Results first posted
Jan 22, 2021
Last update
Jan 22, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03318783
Collaborators
Foundation for Anesthesia Education and Research, GlaxoSmithKline
Responsible party
Ross Martini, MD (Principal Investigator, Oregon Health and Science University) — Principal investigator
First posted
Oct 24, 2017
Start date
May 2, 2018
Primary completion
Apr 3, 2019
Completion
Jan 9, 2020
Results posted
Jan 22, 2021
Last update
Jan 22, 2021

Study contacts

Ross Martini, MD
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Gsk-2256294

Start the discussion