Post Abdominal Surgery PainPhase 2/3NCT02542384
A Study Evaluating the Overall Pain Relief and Safety of Intravenous (IV) CR845 in Patients Undergoing Abdominal Surgery
A Phase 2/3 study testing CR845 IV 1 mcg/kg and CR845 IV 0.5 mcg/kg in people with Post Abdominal Surgery Pain, run by Cara Therapeutics, Inc. at 23 sites in United States.
Trial summary
The study schedule is comprised of a 14-day Screening Period, a treatment period and an observation period. All eligible subjects will be randomized into one of 3 treatment groups (1 of 2 dose levels or matched placebo). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Post Abdominal Surgery Pain
- What is being tested?
- CR845 IV 1 mcg/kg and CR845 IV 0.5 mcg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 451 participants
- Where
- 23 sitesUnited States
- Study dates
- Sep 2015to Jun 2018
- Phase
- Phase 2/3
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A patient will be eligible for study participation if the subject meets the following criteria:
- Voluntarily provide written informed consent to participate in the study prior to any study procedures.
- Able to speak, read, and communicate clearly in English or Spanish; able to read and understand the study procedures.
- Male or female between 21 and older at the time of Screening.
- Scheduled for abdominal surgery (hysterectomy; prostatectomy; hemi-colectomy (including partial bowel resections) or ventral hernia repair) with no collateral procedures.
- Patient is categorized as American Society of Anesthesiologists (ASA) risk class of I, II or III.
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- Has a body mass index (BMI) within 18.0-40.0 kg/m2 and weight between 50 kg and 112 kg, inclusive.
- For women of childbearing potential- has a negative result on serum pregnancy testing at Screening and urine pregnancy test at Admission and does not currently breast feed, or is planning to do so within 30 days of receiving the last dose of study drug.
- If female, the patient must be:
- Of childbearing potential and practicing an acceptable form of birth control (defined as the use of an intrauterine device; a barrier method with spermicide; condoms, any form of hormonal contraceptives; or abstinence from sexual intercourse) for 3 days following the last dose of study drug.
- Of non-childbearing potential defined as surgically or biologically sterile (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or postmenopausal for at least 1 year).
- If male, the patient must be surgically or biologically sterile. If not sterile, the patient must agree to use an acceptable form of birth control with heterosexual partner (as described in inclusion criteria #8a) or abstain from sexual relations for 3 days following the last dose of study drug.
- Is free of other physical, mental, or medical conditions, which, in the opinion of the Investigator, would make study participation inadvisable.
- Following surgery, the patient will be eligible for the second dose of study drug.
Who cannot join
- A patient will be excluded from the study if any of the following criteria are met:
- Has a serum sodium level > 143 mmol/L at Screening.
- Has a serum sodium level < 136 mmol/L at Screening.
- Patient is unwilling or unable to comply with the study procedures and assessments until the end of the 48-hour treatment and observation period.
- Has moderate to severe obstructive sleep apnea, which, in the opinion of the Investigator is not being adequately treated (i.e., Nasal/Facial C-PAP), and will pose an unacceptable risk.
- Has known allergies or hypersensitivity to drugs that may be used during the study, including those used during the surgical procedure and in the post-operative period [e.g., inhaled anesthetics (such as sevoflurane), midazolam, opioids (such as fentanyl and morphine sulfate), propofol or other sedatives, local anesthetics, antiemetics (such as ondansetron) non- steroidal anti-inflammatory drugs (such as ketorolac) or acetaminophen].
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- Uses antipsychotics, antiepileptics, sedatives, hypnotics, or antianxiety agents, selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants with a dose change < 30 days prior to surgery.
- Has a history or current diagnosis of substance dependence (except caffeine or nicotine) or alcohol abuse, according to the criteria of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- Has a positive urine drug screen for drugs of abuse at Screening.
- Is unwilling to abstain from alcohol consumption for a period beginning 24 hours prior to Admission until the time of Discharge from the hospital.
- Suffers from chronic dizziness, vestibular disorders, or has experienced severe continuous diarrhea, retching, vomiting, or moderate or severe nausea and/or dizziness for any reason within 72 hours prior to Admission.
- Has been diagnosed with a condition of hyperhidrosis (excessive sweating) or primary hypodipsia (abnormally diminished thirst).
- Has donated or had significant loss of whole blood (240 mL or more) within 30 days or plasma within 14 days prior to Admission.
- Has a history (within 6 months) of clinically meaningful orthostatic changes in vital signs - OR - a decrease in systolic blood pressure by > 20 mm Hg or a decrease in diastolic blood pressure by 10 mm Hg together with an increase in heart rate of > 30 beats per minute when transitioning from supine to standing measurements at the time of Screening.
- Hasmedicalconditions(e.g.,cardiovascular,pulmonary,hepatic,renal, hematologic, gastrointestinal, endocrine (adrenal hyperplasia), immunologic, dermatologic, neurologic, oncologic or psychiatric condition) or a significant laboratory abnormality that, in the Investigator's opinion, would jeopardize the safety of the patient or is likely to confound the study measurements.
- Has congestive heart failure.
- Has taken any diuretic medications within 2-weeks prior to the scheduled surgery.
- Has an oxygen saturation < 92% on room air at Screening or Admission.
- Has impaired renal function indicated by serum creatinine greater than 2 times the reference upper limit of normal (ULN).
- Has a serum alanine aminotransferase (ALT) or aspartate aminotransferase AST) greater than 2.5 times the reference upper limit of normal (ULN), or total bilirubin greater than 2 times the ULN at Screening.
- Has, in the opinion of the Investigator, any clinical signs of dehydration or hypovolemia (e.g., symptomatic hypotension) or associated laboratory abnormalities, e.g., elevated hematocrit, elevated blood urea nitrogen (BUN) >1.5 x the reference ULN at Screening.
- Has taken opioid analgesics for more than 10 consecutive days for any reason within the past 3 months prior to Screening.
- Has taken opioid or non-opioid pain medication (e.g., NSAIDs such as naproxen, cyclooxygenase-2 inhibitors) within the 12 hours prior to surgery.
- Has received another investigational drug within 30 days prior to Admission or has planned to participate in another clinical trial while enrolled in this study.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Cara Therapeutics Study Site
Bellaire, Texas
Cara Therapeutics Study Site
Boston, Massachusetts
Cara Therapeutics Study Site
Bradenton, Florida, 34209
Cara Therapeutics Study Site
Camden, New Jersey, 08103
Cara Therapeutics Study Site
Chattanooga, Tennessee
Cara Therapeutics Study Site
Chicago, Illinois
Cara Therapeutics Study Site
Cleveland, Ohio
Cara Therapeutics Study Site
Columbus, Ohio
Cara Therapeutics Study Site
Durham, North Carolina, 27710
Cara Therapeutics Study Site
Fort Worth, Texas
Cara Therapeutics Study Site
Gainesville, Florida
Cara Therapeutics Study Site
Houston, Texas
Cara Therapeutics Study Site
Maitland, Florida
Cara Therapeutics Study Site
Miami Gardens, Florida
Cara Therapeutics Study Site
Neptune City, New Jersey
Cara Therapeutics Study Site
New Haven, Connecticut
Cara Therapeutics Study Site
Pensacola, Florida, 32503
Cara Therapeutics Study Site
Pittsburgh, Pennsylvania
Cara Therapeutics Study Site
Plano, Texas
Cara Therapeutics Study Site
Salt Lake City, Utah, 84124
Cara Therapeutics Study Site
San Antonio, Texas
Cara Therapeutics Study Site
Sheffield, Alabama
Cara Therapeutics Study Site
St. Petersburg, Florida, 33713
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study Evaluating the Analgesic Efficacy and Safety of Intravenous CR845 in Patients Undergoing Abdominal Surgery
The study schedule is comprised of a 14-day Screening Period, a treatment period and an observation period. All eligible subjects will be randomized into one of 3 treatment groups (1 of 2 dose levels or matched placebo). Study drug CR845 will be administered intravenously prior to surgery, and at specific time intervals post surgery. Additional rescue pain and anti-nausea medication will be made available. Post surgical changes in pain intensity, nausea and vomiting will be assessed.
Read the detailed description
Patients will be admitted to the surgical center on the day of their abdominal surgery (Day 1, unless admission the night before is required). All patients will be seen by the study staff to confirm eligibility, review study procedures, and conduct all pre-surgical assessments required for randomization.
Qualified patients will be randomized into 1 of 3 treatment groups, corresponding to 1 of 2 dose levels of intravenous (IV) CR845 (0.5 or 1 mcg/kg) or matched placebo, respectively.
Study drug will be administered every 6 hours during the 24-hour post-operative treatment period following these initial 2 drug administrations:
- Pre-Operative dose: Within one hour prior to anesthetic induction for surgery. This dose will be a 2X loading dose.
- Baseline post-operative dose: within 30-minutes of being considered stable in the Post-Anesthesia Care Unit (PACU)
Subsequent dosing will be administered at 6, 12 and 18 hours.
During the Treatment and Observation Period, pain intensity scores will be obtained at specified time points and episodes of nausea or vomiting will be recorded. Upon request, patients may be provided with analgesic or anti-nausea rescue medication (restricted to morphine (if tolerated), and ondansetron, respectively) at any time after the Baseline dose of study drug is administered.
Blood sampling and safety assessments will be conducted during this period as well.
Patients will remain in the hospital until Day 3 (48-hours after surgery) at which point they will be evaluated for discharge. A follow-up medical evaluation will be scheduled within 7 - 10 days post-surgery.
- Conditions
- Post Abdominal Surgery Pain
- Being tested
- CR845 IV 1 mcg/kg, CR845 IV 0.5 mcg/kg, Placebo IV
- Keywords
- abdominal surgery, laparoscopy, Hysterectomy, Prostatectomy, Hemi-colectomy, Ventral Hernia repair, CR845, analgesic, kappa opioid, partial bowel resection, difelikefalin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CR845 IV 1 mcg/kgDrug
CR845 IV 1 mcg/kg will be administered as an IV bolus 2x loading dose one hour prior to anesthetic induction for surgery, then a dose within 30 minutes of the patient being considered stable in the post operative recovery room. Subsequent dosing will be administered at 6, 12 and 18 hours.
Antinausea rescue medication (ondansetron 4 mg IV) may be requested, as well as analgesic rescue medication (morphine 5mg IV), post surgery, as needed. Saline infusion (IV 0.45%) for fluid replenishment will be provided.
CR845 IV 0.5 mcg/kgDrug
CR845 IV 0.5 mcg/kg will be administered as an IV bolus 2x loading dose one hour prior to anesthetic induction for surgery, then a dose within 30 minutes of the patient being considered stable in the post operative recovery room. Subsequent dosing will be administered at 6, 12 and 18 hours.
Antinausea rescue medication (ondansetron 4 mg IV) may be requested, as well as analgesic rescue medication (morphine 5mg IV), post surgery, as needed.
Saline infusion (IV 0.45%) for fluid replenishment will be provided.
Placebo IVDrug
Placebo IV will be administered as an IV bolus 2x loading dose one hour prior to anesthetic induction for surgery, then a dose within 30 minutes of the patient being considered stable in the post operative recovery room. Subsequent dosing will be administered at 6, 12 and 18 hours.
Antinausea rescue medication (ondansetron 4 mg IV) may be requested, as well as analgesic rescue medication (morphine 5mg IV), post surgery, as needed.
Saline infusion (IV 0.45%) for fluid replenishment will be provided.
| Study group | Role | What they receive |
|---|---|---|
| CR845 IV 1 mcg/kg | Active comparator | CR845 IV solution will be supplied in 2 mL glass vials.Study drug will be administered as an IV bolus into an infusion line, the volume is dependent upon the patient's body weight. Receives: Drug: CR845 IV 1 mcg/kg |
| CR845 IV 0.5 mcg/kg | Active comparator | CR845 solution will be supplied in 2 mL glass vials. Study drug will be administered as an IV bolus into an infusion line, the volume is dependent upon the patient's body weight. Receives: Drug: CR845 IV 0.5 mcg/kg |
| Placebo IV | Placebo comparator | Placebo will be supplied in matched vials containing the same volume of buffer but with no active drug. It will be administered as an IV bolus into an infusion line, the volume is dependent upon the patient's body weight. Receives: Drug: Placebo IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
A comparison of the change in Pain Intensity over time using the Numeric Rating Scale
Using the Numeric Rating Scale (NRS) to quantify the difference between CR845-treated patients and placebo-treated patients.
Measured: 24 hours
Secondary outcomes (3)
A study of the comparison of Post Surgical Nausea and Vomiting (PONV) scores
Incidence of vomiting will be analyzed against placebo
Measured: 6 hours
A comparison of the number of rescue medication doses administered
Count the number of rescue medication doses administered following surgery for the CR845 IV patients vs Placebo-treated patients
Measured: 24 hours
Patient Global Assessment of study drug
Patients will complete a PGA (Patient Global Assessment) of the study drug.
Measured: 24 hours (or early termination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionApr 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Abdominal Surgery PainStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cara Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Stauffer, DO, MBA, Study director, Cara Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542384
- Sponsor's protocol ID
- CR845-CLIN3001
- Status last verified
- May 2019
- First submitted
- 3 Sep 2015
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Adaptive Design Study Evaluating the Analgesic Efficacy and Safety of Intravenous CR845 in Patients Undergoing Abdominal Surgery
- ClinicalTrials.gov ID
- NCT02542384
- Acronym / sponsor ID
- CR845-CLIN3001
- Conditions
- Post Abdominal Surgery Pain
- Keywords
- abdominal surgery, laparoscopy, Hysterectomy, Prostatectomy, Hemi-colectomy, Ventral Hernia repair, CR845, analgesic
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Cara Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 7 Sep 2015 (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 study schedule is comprised of a 14-day Screening Period, a treatment period and an observation period. All eligible subjects will be randomized into one of 3 treatment groups (1 of 2 dose levels or matched placebo). Study drug CR845 will be administered intravenously prior to surgery, and at specific time intervals post surgery. Additional rescue pain and anti-nausea medication will be made available. Post surgical changes in pain intensity, nausea and vomiting will be assessed.
Detailed description
Patients will be admitted to the surgical center on the day of their abdominal surgery (Day 1, unless admission the night before is required). All patients will be seen by the study staff to confirm eligibility, review study procedures, and conduct all pre-surgical assessments required for randomization.
Qualified patients will be randomized into 1 of 3 treatment groups, corresponding to 1 of 2 dose levels of intravenous (IV) CR845 (0.5 or 1 mcg/kg) or matched placebo, respectively.
Study drug will be administered every 6 hours during the 24-hour post-operative treatment period following these initial 2 drug administrations:
- Pre-Operative dose: Within one hour prior to anesthetic induction for surgery. This dose will be a 2X loading dose.
- Baseline post-operative dose: within 30-minutes of being considered stable in the Post-Anesthesia Care Unit (PACU)
Subsequent dosing will be administered at 6, 12 and 18 hours.
During the Treatment and Observation Period, pain intensity scores will be obtained at specified time points and episodes of nausea or vomiting will be recorded. Upon request, patients may be provided with analgesic or anti-nausea rescue medication (restricted to morphine (if tolerated), and ondansetron, respectively) at any time after the Baseline dose of study drug is administered.
Blood sampling and safety assessments will be conducted during this period as well.
Patients will remain in the hospital until Day 3 (48-hours after surgery) at which point they will be evaluated for discharge. A follow-up medical evaluation will be scheduled within 7 - 10 days post-surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CR845 IV 1 mcg/kg | Active comparator | Drug: CR845 IV 1 mcg/kgCR845 IV solution will be supplied in 2 mL glass vials.Study drug will be administered as an IV bolus into an infusion line, the volume is dependent upon the patient's body weight. |
| CR845 IV 0.5 mcg/kg | Active comparator | Drug: CR845 IV 0.5 mcg/kgCR845 solution will be supplied in 2 mL glass vials. Study drug will be administered as an IV bolus into an infusion line, the volume is dependent upon the patient's body weight. |
| Placebo IV | Placebo comparator | Drug: Placebo IVPlacebo will be supplied in matched vials containing the same volume of buffer but with no active drug. It will be administered as an IV bolus into an infusion line, the volume is dependent upon the patient's body weight. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- A patient will be eligible for study participation if the subject meets the following criteria:
- Voluntarily provide written informed consent to participate in the study prior to any study procedures.
- Able to speak, read, and communicate clearly in English or Spanish; able to read and understand the study procedures.
- Male or female between 21 and older at the time of Screening.
- Scheduled for abdominal surgery (hysterectomy; prostatectomy; hemi-colectomy (including partial bowel resections) or ventral hernia repair) with no collateral procedures.
Key exclusion criteria (24 listed)
- Has a serum sodium level > 143 mmol/L at Screening.
- Has a serum sodium level < 136 mmol/L at Screening.
- Patient is unwilling or unable to comply with the study procedures and assessments until the end of the 48-hour treatment and observation period.
- Has moderate to severe obstructive sleep apnea, which, in the opinion of the Investigator is not being adequately treated (i.e., Nasal/Facial C-PAP), and will pose an unacceptable risk.
- Has known allergies or hypersensitivity to drugs that may be used during the study, including those used during the surgical procedure and in the post-operative period [e.g., inhaled anesthetics (such as sevoflurane), midazolam, opioids (such as fentanyl and morphine sulfate), propofol or other sedatives, local anesthetics, antiemetics (such as ondansetron) non- steroidal anti-inflammatory drugs (such as ketorolac) or acetaminophen].
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 |
|---|---|---|
| CR845 IV 1 mcg/kgCR845 IV 1 mcg/kg will be administered as an IV bolus 2x loading dose one hour prior to anesthetic induction for surgery, then a dose within 30 minutes of the patient being considered stable in the post operative recovery room. Subsequent dosing will be administered at 6, 12 and 18 hours. Antinausea rescue medication (ondansetron 4 mg IV) may be requested, as well as analgesic rescue medication (morphine 5mg IV), post surgery, as needed. Saline infusion (IV 0.45%) for fluid replenishment will be provided. | Drug | CR845 IV 1 mcg/kg |
| CR845 IV 0.5 mcg/kgCR845 IV 0.5 mcg/kg will be administered as an IV bolus 2x loading dose one hour prior to anesthetic induction for surgery, then a dose within 30 minutes of the patient being considered stable in the post operative recovery room. Subsequent dosing will be administered at 6, 12 and 18 hours. Antinausea rescue medication (ondansetron 4 mg IV) may be requested, as well as analgesic rescue medication (morphine 5mg IV), post surgery, as needed. Saline infusion (IV 0.45%) for fluid replenishment will be provided. | Drug | CR845 IV 0.5 mcg/kg |
| Placebo IVPlacebo IV will be administered as an IV bolus 2x loading dose one hour prior to anesthetic induction for surgery, then a dose within 30 minutes of the patient being considered stable in the post operative recovery room. Subsequent dosing will be administered at 6, 12 and 18 hours. Antinausea rescue medication (ondansetron 4 mg IV) may be requested, as well as analgesic rescue medication (morphine 5mg IV), post surgery, as needed. Saline infusion (IV 0.45%) for fluid replenishment will be provided. | Drug | Placebo IV |
Primary outcome
A comparison of the change in Pain Intensity over time using the Numeric Rating Scale
Time frame: 24 hours
Using the Numeric Rating Scale (NRS) to quantify the difference between CR845-treated patients and placebo-treated patients.
3 secondary outcomes
A study of the comparison of Post Surgical Nausea and Vomiting (PONV) scores
Time frame: 6 hours
A comparison of the number of rescue medication doses administered
Time frame: 24 hours
Patient Global Assessment of study drug
Time frame: 24 hours (or early termination)
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 31 May 2019.
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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.
Joseph Stauffer, DO, MBA study director
Cara Therapeutics
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CR845 IV 1 mcg/kg and CR845 IV 0.5 mcg/kg in people with Post Abdominal Surgery Pain, run by Cara Therapeutics, Inc. at 23 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 14 inclusion and 24 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 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
A comparison of the change in Pain Intensity over time using the Numeric Rating Scale (time frame: 24 hours). 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 31 May 2019.