Spinal FusionPhase 1NCT02985762
PK Study of EXPAREL in Subjects Undergoing Open Spinal Fusion or Reconstructive Surgery
A Phase 1 study testing EXPAREL in people with Spinal Fusion and Pain Management, run by Pacira Pharmaceuticals, Inc at 3 sites in United States.
Trial summary
The primary objective of this study is to characterize the pharmacokinetic (PK) profile of EXPAREL when administered via local wound infiltration to subjects undergoing open spinal fusion or reconstructive surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Fusion, Pain Management
- What is being tested?
- EXPAREL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2016to Sep 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females ≥18 years of age.
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
- Scheduled to undergo primary, ≥3 level cervical or thoracic spine fusion or reconstruction under general anesthesia. The surgical incision must be at least 8 cm in length.
- Female subject must be surgically sterile; or at least 2 years postmenopausal; or have a monogamous partner who is surgically sterile; or practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening and commit to the use of an acceptable form of birth control for the duration of the study and for 30 days after completion of the study.
- Able to provide informed consent, adhere to the study schedule, and complete all study assessments.
Who cannot join
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics or opioids.
- Contraindication to bupivacaine.
- Received bupivacaine or any other local anesthetic within 7 days of screening.
- Receiving workers' compensation.
- Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
- Non-structural or acute spinal conditions (e.g., cauda equina syndrome, infection, tumor, fracture).
Show all 20Show fewer
- Planned concurrent surgical procedure.
- Comorbidity impacting current physical function or Investigator opinion that it may impact postsurgical rehabilitation.
- Body weight <50 kg (110 pounds) or a body mass index ≥45 kg/m2.
- History of coronary or vascular stent placed within the past 3 months (may be extended to 1 year if medically indicated per physician discretion).
- Have been treated for a deep vein thrombosis, pulmonary embolism, myocardial infarction, or ischemic stroke within the past 6 months (may be extended to 1 year if medically indicated per physician discretion).
- Severely impaired renal or hepatic function (e.g., serum creatinine level > 2 mg/dL [176.8 μmol/L], blood urea nitrogen level >50 mg/dL [17.9 mmol/L], serum aspartate aminotransferase [AST] level >3 times the upper limit of normal [ULN], or serum alanine aminotransferase [ALT] level > 3 times ULN).
- Any neurologic or psychiatric disorder that might impact postsurgical pain or interfere with study assessments.
- Malignancy in the last 2 years, per physician discretion.
- History of misuse, abuse, or dependence on opioid analgesics, other prescription drugs, illicit drugs, or alcohol.
- Failure to pass the alcohol breath test or urine drug screen.
- Current or historical evidence of any clinically significant disease or condition, especially cardiovascular or neurological conditions that, in the opinion of the Investigator, may increase the risk of surgery or complicate the subject's postsurgical course.
- Clinically significant medical or psychiatric disease that, in the opinion of the Investigator, would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements.
- Received any investigational drug within 30 days prior to study drug administration, and/or has planned administration of another investigational product or procedure during the subject's participation in this study.
- Previous participation in an EXPAREL study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
University of Miami
Miami, Florida, 33136
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Phase 1, Open-Label Study to Evaluate the Safety and Pharmacokinetics of Local Administration of EXPAREL When Administered for Prolonged Postsurgical Analgesia in Subjects Undergoing Open Spinal Fusion or Reconstructive Surgery
The primary objective of this study is to characterize the pharmacokinetic (PK) profile of EXPAREL when administered via local wound infiltration to subjects undergoing open spinal fusion or reconstructive surgery.
The secondary objectives of this study are to assess the safety, tolerability, and efficacy of EXPAREL in this surgical model.
Read the detailed description
This is a Phase 1, multi-center, open-label study designed to evaluate the safety and pharmacokinetics of EXPAREL when administered via local wound infiltration to subjects undergoing open cervical or thoracic spinal fusion or reconstructive surgery.
Fifteen subjects are planned for enrollment. Eligible subjects, whose surgical incision must be at least 8 cm in length, will receive a single dose of EXPAREL (266 mg/20 mL) expanded in volume with 20-60 mL normal saline, depending on the size of the incision. Incision will be performed using a posterior surgical approach.
Administration Technique:
Study drug should be injected in the prescribed locations based on the areas of highest nerve density. Study drug will be administered using syringes with 22-gauge needles prior to wound closure. The Investigator must document the size of the incision. Each infiltration site should be spaced 1.0-1.5 cm apart and should deliver approximately 1-1.5 mL into both deep and superficial areas (para-spinous fascia, muscle, and subcutaneous layers). As each incision will have three layers of infiltration, the total volume to be infiltrated can range from 40-80 mL (please refer to below specifics on how to determine total volume of expansion). Following infiltration, the tissue should visibly expand with minimal leakage.
Total Volume of Expansion:
The Investigator must document the total volume used for each surgery.
- EXPAREL (20 mL) + normal saline (20-60 mL based on the incision size) = total volume.
- For example: If the infiltration sites are 1.5 cm apart, then a 10 cm incision would be 10 × 2 sides × 3 layers = 60 cm. If there is 1 mL infiltrated every 1.5 cm, the total volume would be 40 mL.
Screening:
Subjects will be screened within 30 days prior to study drug administration. During the screening visit, which must take place at least 1 day prior to surgery, subjects will be assessed for past or present neurologic, cardiac, and general medical conditions that in the opinion of the Investigator would preclude them from study participation. After the informed consent form (ICF) is signed, a medical/surgical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), neurological assessment, alcohol breath test, urine drug screen, and urine pregnancy test for women of childbearing potential will be conducted.
Trained and qualified Investigators will use their usual standard of care surgical technique to perform the surgery. The use of fentanyl or analogues will be permitted (during surgery only). Intraoperative administration of other opioids or any other analgesic, local anesthetics, or anti-inflammatory agents will be prohibited unless needed to treat an adverse event (AE).
Subjects must remain in the hospital for at least 72 hours after surgery in order to undergo postsurgical assessments. In addition, subjects must return for the 84 hour and 96 hour study assessments.
Day 7 Follow-Up Visit:
All subjects will return on Day 7 for a follow-up visit, which will include vital sign measurements, 12-lead ECG, neurological assessment, blood sample collection for PK analysis, and an AE assessment.
Postsurgical Safety Assessments:
This will include a cardiac assessment (i.e., 12-lead ECG), neurological assessment, and vital signs. Adverse events will be recorded from the time the ICF is signed through Day 30. If a cardiac or neurological AE of special interest or SAE occurs during the study, an unscheduled PK blood sample must be collected. In addition, a 12-lead ECG, vital signs, and any appropriate clinical laboratory tests must be conducted. Cardiac AEs of special interest include chest pain (angina, myocardial infarction), abnormal/irregular heart rate (bradycardia, tachycardia, extrasystoles), and shortness of breath requiring intervention. Neurologic AEs of special interest include altered mental status/altered sensorium, rigidity, dysarthria, seizure, tremors, metallic taste, tinnitus, perioral numbness, visual disturbance, and severe or worsening dizziness. Additionally, the following events are of special interest if they persist or occur beyond 72-hours postdose: dizziness, hyperesthesia, muscular twitching, and tingling/paresthesia.
Postsurgical Efficacy Assessments
Will include pain intensity scores using a 10 cm visual analog scale (VAS) and use of supplemental opioid rescue medication.
Pharmacokinetic Assessment:
Blood samples for PK analysis will be obtained predose (on Day 1 prior to study drug administration); 15 minutes, 30 minutes, 1, 2, 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after the beginning of study drug administration; and on Day 7.
Number of Planned Patients for enrollment is 15 adult subjects.
- Conditions
- Spinal Fusion, Pain Management
- Being tested
- EXPAREL
- Keywords
- bupivacaine, exparel, analgesic, lumbar spine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXPARELDrug
| Study group | Role | What they receive |
|---|---|---|
| EXPAREL 266 mg/20 mL | Other | Eligible subjects, whose surgical incision must be at least 8 cm in length, will receive a single dose of EXPAREL (266 mg/20 mL) expanded in volume with 20-60 mL normal saline, depending on the size of the incision Receives: Drug: EXPAREL |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the plasma concentration-versus-time curve from the time of administration extrapolated to infinity. The residual area from the time of the last quantifiable concentration (Ctlast) to infinity is to be calculated using the approximation
Measured: 7 days
The VAS pain intensity scores at each assessed timepoint
Pain intensity scores using the VAS at predose (on Day 1 prior to study drug administration); upon arrival at the post-anesthesia care unit (PACU); at 4, 8, 12, 24, 36, 48, 60, and 72 hours after the beginning of study drug administration; immediately prior to each administration of rescue pain medication; and just prior to hospital discharge
Measured: 72 hours
Total inpatient postsurgical opioid consumption (in mg) through 72 hours or hospital discharge
Measured: 72 hours
Time to first opioid rescue through 72 hours or hospital discharge
Measured: 72 hours
The area under the plasma concentration-versus-time curve from the time of administration to the time of the last quantifiable concentration calculated using the log-linear trapezoidal rule
Pharmacokinetic parameters will be estimated from plasma bupivacaine measurements using non-compartmental analysis, based on the sampling schedule at predose (on Day 1 prior to study drug administration); 15 minutes, 30 minutes, 1, 2, 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after the beginning of study drug administration; and on Day 7
Measured: 7 days
The maximum observed plasma concentration obtained directly from the experimental data without interpolation. Overall, early Cmax (occurring within 2 hours postdose) and late Cmax (occurring after 2 hours postdose) will be presented
Measured: 7 days
The time to maximum plasma concentration (Cmax). Overall, early, and late Tmax will be presented
Measured: 7 days
The apparent terminal elimination rate constant determined by log-linear regression of the terminal log-linear segment of the plasma concentration-versus-time curve
Measured: 7 days
The apparent terminal elimination half-life calculated as 0.693/λz
Measured: 7 days
Incidence of TEAEs through Day 30
Measured: 30 days
Summary of neurological assessments (proportion of subjects who are oriented and proportion of subjects who have any of the neurological events
Measured: 30 days
Change from baseline in ECG data closest to the median Tmax
Measured: 30 days
Investigator assessment of the ECG (normal, abnormal - not clinically significant, abnormal - clinically significant)
Measured: 30 days
Change from baseline in vital signs at each assessed timepoint
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FusionStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacira Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hassan Danesi, MD, Study director, Pacira Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985762
- Sponsor's protocol ID
- 402-C-117
- Status last verified
- Apr 2018
- First submitted
- 2 Dec 2016
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Evaluate the Safety and Pharmacokinetics of Local Administration of EXPAREL When Administered for Prolonged Postsurgical Analgesia in Subjects Undergoing Open Spinal Fusion or Reconstructive Surgery
- ClinicalTrials.gov ID
- NCT02985762
- Acronym / sponsor ID
- 402-C-117
- Conditions
- Spinal Fusion, Pain Management
- Keywords
- bupivacaine, exparel, analgesic, lumbar spine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Pacira Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to characterize the pharmacokinetic (PK) profile of EXPAREL when administered via local wound infiltration to subjects undergoing open spinal fusion or reconstructive surgery.
The secondary objectives of this study are to assess the safety, tolerability, and efficacy of EXPAREL in this surgical model.
Detailed description
This is a Phase 1, multi-center, open-label study designed to evaluate the safety and pharmacokinetics of EXPAREL when administered via local wound infiltration to subjects undergoing open cervical or thoracic spinal fusion or reconstructive surgery.
Fifteen subjects are planned for enrollment. Eligible subjects, whose surgical incision must be at least 8 cm in length, will receive a single dose of EXPAREL (266 mg/20 mL) expanded in volume with 20-60 mL normal saline, depending on the size of the incision. Incision will be performed using a posterior surgical approach.
Administration Technique:
Study drug should be injected in the prescribed locations based on the areas of highest nerve density. Study drug will be administered using syringes with 22-gauge needles prior to wound closure. The Investigator must document the size of the incision. Each infiltration site should be spaced 1.0-1.5 cm apart and should deliver approximately 1-1.5 mL into both deep and superficial areas (para-spinous fascia, muscle, and subcutaneous layers). As each incision will have three layers of infiltration, the total volume to be infiltrated can range from 40-80 mL (please refer to below specifics on how to determine total volume of expansion). Following infiltration, the tissue should visibly expand with minimal leakage.
Total Volume of Expansion:
The Investigator must document the total volume used for each surgery.
- EXPAREL (20 mL) + normal saline (20-60 mL based on the incision size) = total volume.
- For example: If the infiltration sites are 1.5 cm apart, then a 10 cm incision would be 10 × 2 sides × 3 layers = 60 cm. If there is 1 mL infiltrated every 1.5 cm, the total volume would be 40 mL.
Screening:
Subjects will be screened within 30 days prior to study drug administration. During the screening visit, which must take place at least 1 day prior to surgery, subjects will be assessed for past or present neurologic, cardiac, and general medical conditions that in the opinion of the Investigator would preclude them from study participation. After the informed consent form (ICF) is signed, a medical/surgical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), neurological assessment, alcohol breath test, urine drug screen, and urine pregnancy test for women of childbearing potential will be conducted.
Trained and qualified Investigators will use their usual standard of care surgical technique to perform the surgery. The use of fentanyl or analogues will be permitted (during surgery only). Intraoperative administration of other opioids or any other analgesic, local anesthetics, or anti-inflammatory agents will be prohibited unless needed to treat an adverse event (AE).
Subjects must remain in the hospital for at least 72 hours after surgery in order to undergo postsurgical assessments. In addition, subjects must return for the 84 hour and 96 hour study assessments.
Day 7 Follow-Up Visit:
All subjects will return on Day 7 for a follow-up visit, which will include vital sign measurements, 12-lead ECG, neurological assessment, blood sample collection for PK analysis, and an AE assessment.
Postsurgical Safety Assessments:
This will include a cardiac assessment (i.e., 12-lead ECG), neurological assessment, and vital signs. Adverse events will be recorded from the time the ICF is signed through Day 30. If a cardiac or neurological AE of special interest or SAE occurs during the study, an unscheduled PK blood sample must be collected. In addition, a 12-lead ECG, vital signs, and any appropriate clinical laboratory tests must be conducted. Cardiac AEs of special interest include chest pain (angina, myocardial infarction), abnormal/irregular heart rate (bradycardia, tachycardia, extrasystoles), and shortness of breath requiring intervention. Neurologic AEs of special interest include altered mental status/altered sensorium, rigidity, dysarthria, seizure, tremors, metallic taste, tinnitus, perioral numbness, visual disturbance, and severe or worsening dizziness. Additionally, the following events are of special interest if they persist or occur beyond 72-hours postdose: dizziness, hyperesthesia, muscular twitching, and tingling/paresthesia.
Postsurgical Efficacy Assessments
Will include pain intensity scores using a 10 cm visual analog scale (VAS) and use of supplemental opioid rescue medication.
Pharmacokinetic Assessment:
Blood samples for PK analysis will be obtained predose (on Day 1 prior to study drug administration); 15 minutes, 30 minutes, 1, 2, 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after the beginning of study drug administration; and on Day 7.
Number of Planned Patients for enrollment is 15 adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EXPAREL 266 mg/20 mL | Other | Drug: EXPARELEligible subjects, whose surgical incision must be at least 8 cm in length, will receive a single dose of EXPAREL (266 mg/20 mL) expanded in volume with 20-60 mL normal saline, depending on the size of the incision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males or females ≥18 years of age.
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
- Scheduled to undergo primary, ≥3 level cervical or thoracic spine fusion or reconstruction under general anesthesia. The surgical incision must be at least 8 cm in length.
- Female subject must be surgically sterile; or at least 2 years postmenopausal; or have a monogamous partner who is surgically sterile; or practicing double-barrier contraception; or practicing abstinence (must agree to use double-barrier contraception in the event of sexual activity); or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA for greater than 2 months prior to screening and commit to the use of an acceptable form of birth control for the duration of the study and for 30 days after completion of the study.
- Able to provide informed consent, adhere to the study schedule, and complete all study assessments.
Key exclusion criteria (20 listed)
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics or opioids.
- Contraindication to bupivacaine.
- Received bupivacaine or any other local anesthetic within 7 days of screening.
- Receiving workers' compensation.
- Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
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 |
|---|---|---|
| EXPAREL | Drug | EXPAREL 266 mg/20 mL |
Primary outcome
The area under the plasma concentration-versus-time curve from the time of administration extrapolated to infinity. The residual area from the time of the last quantifiable concentration (Ctlast) to infinity is to be calculated using the approximation
Time frame: 7 days
The VAS pain intensity scores at each assessed timepoint
Time frame: 72 hours
Pain intensity scores using the VAS at predose (on Day 1 prior to study drug administration); upon arrival at the post-anesthesia care unit (PACU); at 4, 8, 12, 24, 36, 48, 60, and 72 hours after the beginning of study drug administration; immediately prior to each administration of rescue pain medication; and just prior to hospital discharge
Total inpatient postsurgical opioid consumption (in mg) through 72 hours or hospital discharge
Time frame: 72 hours
Time to first opioid rescue through 72 hours or hospital discharge
Time frame: 72 hours
The area under the plasma concentration-versus-time curve from the time of administration to the time of the last quantifiable concentration calculated using the log-linear trapezoidal rule
Time frame: 7 days
Pharmacokinetic parameters will be estimated from plasma bupivacaine measurements using non-compartmental analysis, based on the sampling schedule at predose (on Day 1 prior to study drug administration); 15 minutes, 30 minutes, 1, 2, 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after the beginning of study drug administration; and on Day 7
The maximum observed plasma concentration obtained directly from the experimental data without interpolation. Overall, early Cmax (occurring within 2 hours postdose) and late Cmax (occurring after 2 hours postdose) will be presented
Time frame: 7 days
The time to maximum plasma concentration (Cmax). Overall, early, and late Tmax will be presented
Time frame: 7 days
The apparent terminal elimination rate constant determined by log-linear regression of the terminal log-linear segment of the plasma concentration-versus-time curve
Time frame: 7 days
The apparent terminal elimination half-life calculated as 0.693/λz
Time frame: 7 days
Incidence of TEAEs through Day 30
Time frame: 30 days
Summary of neurological assessments (proportion of subjects who are oriented and proportion of subjects who have any of the neurological events
Time frame: 30 days
Change from baseline in ECG data closest to the median Tmax
Time frame: 30 days
Investigator assessment of the ECG (normal, abnormal - not clinically significant, abnormal - clinically significant)
Time frame: 30 days
Change from baseline in vital signs at each assessed timepoint
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Hassan Danesi, MD study director
Pacira Pharmaceuticals, Inc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EXPAREL in people with Spinal Fusion and Pain Management, run by Pacira Pharmaceuticals, Inc at 3 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 5 inclusion and 20 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 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The area under the plasma concentration-versus-time curve from the time of administration extrapolated to infinity. The residual area from the time of the last quantifiable concentration (Ctlast) to infinity is to be calculated using the approximation (time frame: 7 days). The study lists 14 primary outcomes in all. 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 10 Apr 2018.