Renal ColicPhase 1/2NCT04160520
Pramipexole and Morphine for Renal Colic
A Phase 1/2 study testing Pramipexole and Morphine in people with Renal Colic, run by East Carolina University at 1 site in United States.
Trial summary
Opioid analgesics are among the most commonly prescribed class of medications in the US. While opioids may effectively control pain and other sensory disorders under acute conditions, the rates of misuse/abuse and accidental overdose have reached epidemic proportions. Read more about this study
- Who is it for?
- Ages 19 to 66 years
- Conditions the study is for
- Renal Colic
- What is being tested?
- Pramipexole and Morphine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2019to 24 Jan 2023
- Phase
- Phase 1/2
- 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 19 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19 - 65
- ED presentation with pain associated with suspected renal colic
- Patient reported failure to achieve pain relief with NSAID treatment in ED (additional pain treatment needed per treatment team)
Who cannot join
- Age < 19 or ≥ 66
- Allergy to any study medication
- Known pregnancy or breastfeeding
- Received opioid prior to enrollment
- Received IV Lidocaine during current ED visit
- Known chronic renal disease
- Currently taking any dopamine receptor agonist or antagonists (Do I need to list?)
- Unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Vidant Medical Center ED
Greenville, North Carolina, 27834
About this study
Official title: Adjuvant Treatment With Pramipexole to Reduce the Dose of Opioids Necessary for Analgesia in Acute Renal Colic
Opioid analgesics are among the most commonly prescribed class of medications in the US. While opioids may effectively control pain and other sensory disorders under acute conditions, the rates of misuse/abuse and accidental overdose have reached epidemic proportions. Clinicians are being challenged to find alternatives to opioid analgesics, or to reduce their use in treating pain whenever possible. Pre-clinical studies have shown that combining morphine (opioid drug) with pramipexole (dopamine 3 receptor agonist with some D2/D4 action) provides superior analgesia against painful stimuli than morphine alone. This analgesia is maintained even when the dose of morphine is lowered to a dose that is not effective on its own. A recent case report describes the use of this combination to restore pain control in a patient with restless legs syndrome, for which opioids alone have lost their effectiveness (Happe S, Clemens S and Brewer KL, In Review). This application proposes to establish a new therapeutic approach for treatment of a pain associated with renal colic (a common painful condition) using a novel combination of 2 existing, FDA-approved drugs. The immediate goal is to demonstrate that this drug combination can provide similar analgesia to opioid alone, and that analgesia is maintained when the opioid dose is reduced by 50%.
Read the detailed description
This is a double-blinded randomized controlled trial to take place in the Vidant Medical Center (VMC) Emergency Department (ED). A convenience sample of 96 participants will be drawn from patients presenting to the ED presentation with pain associated with suspected renal colic who do not experience pain relief after initial treatment with nonsteroidal anti-inflammatories.
Written informed consent will be sought by a study team member after screening to ensure all inclusion criteria and no exclusion criteria are met. Once a patient has consented, they will be randomized into 1 of 2 study arms: Arm 1 (Control arm) = 0.1mg/kg of intravenous morphine + placebo pill, single dose Arm 2 (Study arm) = 0.05mg/kg intravenous morphine + 0.25mg pramipexole, single dose. Both arms include a maximum dose of 10mg/kg for the IV morphine. Pain scores will be obtained prior to administration of study drugs, and at 15-minute intervals (+/- 2 mins) after treatment for up to 2 hours, or discharge from the ED. Subjective response to each drug treatment will also be assessed every 15 minutes (+/- 2 mins) after treatment for up to 2 hours, or discharge from ED. Morphine will have a max dose of 10mg IV.
- Conditions
- Renal Colic
- Being tested
- Pramipexole, Morphine, Placebo oral tablet
- Keywords
- morphine, Pramipexole, Renal Colic, Kidney Stone, opioids, analgesia, pain relief
- Medical subject headings
- Renal Colic, Kidney Calculi, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PramipexoleDrug
Establish proof of concept that low dose morphine in combination with pramipexole is non-inferior to standard dose morphine with respect to providing analgesia in patients presenting to the ED with pain associated with renal colic.
MorphineDrug
Establish proof of concept that low dose morphine in combination with pramipexole is non-inferior to standard dose morphine with respect to providing analgesia in patients presenting to the ED with pain associated with renal colic.
Placebo oral tabletDrug
Establish proof of concept that low dose morphine in combination with pramipexole is non-inferior to standard dose morphine with respect to providing analgesia in patients presenting to the ED with pain associated with renal colic.
| Study group | Role | What they receive |
|---|---|---|
| Pramipexole and half-standard dose of morphine | Experimental | 0.25 mg oral tablet of pramipexole in combination with 0.05mg/kg of IV morphine Receives: Drug: Pramipexole; Drug: Morphine |
| Standard dose of morphine and placebo | Active comparator | 0.1mg/kg of IV morphine in combination with a placebo pill Receives: Drug: Morphine; Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who have an effective analgesic response (defined as at least a 50% improvement in pain scores) at 120 minutes post-randomization.
Pain scores used are the numerical rating scale (0 low to 10 high) or visual analogue scale (0 low to 100mm high).
Measured: 120 minutes
Total dose of opioid received at 120 minutes in patients reporting a reduction in pain scores from baseline.
Dose of opioid measured in mg/kg
Measured: 120 minutes
Proportion of patients who require rescue medications at 30 minutes post-randomization.
Measured: 30 minutes
Secondary outcomes (2)
Time to reach effective pain reduction (defined as at least a 50% improvement in pain scores) within 120 minutes of treatment.
Pain scores used are the numerical rating scale (0 low to 10 high) or visual analogue scale (0 low to 100mm high).
Measured: 120 minutes
Subjective effects of the drugs measured by scores on the drug effects questionnaire.
Drug effects questionnaire rates symptoms from 'not at all' at 0mm to 'extremely' at 100mm.
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start28 Oct 2019
- Primary completion24 Jan 2023
- Study completion24 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Renal ColicStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kori Brewer, PhD, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160520
- Sponsor's protocol ID
- ECarolinaUniversity
- Status last verified
- Mar 2023
- First submitted
- 5 Nov 2019
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodgers HM, Yow J, Evans E, Clemens S, Brewer KL. Dopamine D1 and D3 receptor modulators restore morphine analgesia and prevent opioid preference in a model of neuropathic pain. Neuroscience. 2019 May 15;406:376-388. doi: 10.1016/j.neuroscience.2019.03.034. Epub 2019 Mar 23.
PubMed 30910641Afshar K, Jafari S, Marks AJ, Eftekhari A, MacNeily AE. Nonsteroidal anti-inflammatory drugs (NSAIDs) and non-opioids for acute renal colic. Cochrane Database Syst Rev. 2015 Jun 29;2015(6):CD006027. doi: 10.1002/14651858.CD006027.pub2.
PubMed 26120804Pathan SA, Mitra B, Bhutta ZA, Qureshi I, Spencer E, Hameed AA, Nadeem S, Tahir R, Anjum S, Cameron PA. A comparative, epidemiological study of acute renal colic presentations to emergency departments in Doha, Qatar, and Melbourne, Australia. Int J Emerg Med. 2018 Jan 3;11(1):1. doi: 10.1186/s12245-017-0160-9.
PubMed 29299773Patanwala AE, Keim SM, Erstad BL. Intravenous opioids for severe acute pain in the emergency department. Ann Pharmacother. 2010 Nov;44(11):1800-9. doi: 10.1345/aph.1P438. Epub 2010 Oct 26.
PubMed 20978218Altun A, Yildirim K, Ozdemir E, Bagcivan I, Gursoy S, Durmus N. Attenuation of morphine antinociceptive tolerance by cannabinoid CB1 and CB2 receptor antagonists. J Physiol Sci. 2015 Sep;65(5):407-15. doi: 10.1007/s12576-015-0379-2. Epub 2015 Apr 18.
PubMed 25894754Altun A, Ozdemir E, Yildirim K, Gursoy S, Durmus N, Bagcivan I. The effects of endocannabinoid receptor agonist anandamide and antagonist rimonabant on opioid analgesia and tolerance in rats. Gen Physiol Biophys. 2015 Oct;34(4):433-40. doi: 10.4149/gpb_2015017.
PubMed 26374993Terner JM, Barrett AC, Lomas LM, Negus SS, Picker MJ. Influence of low doses of naltrexone on morphine antinociception and morphine tolerance in male and female rats of four strains. Pain. 2006 May;122(1-2):90-101. doi: 10.1016/j.pain.2006.01.019. Epub 2006 Mar 9.
PubMed 16527399Dourish CT, Hawley D, Iversen SD. Enhancement of morphine analgesia and prevention of morphine tolerance in the rat by the cholecystokinin antagonist L-364,718. Eur J Pharmacol. 1988 Mar 15;147(3):469-72. doi: 10.1016/0014-2999(88)90183-5.
PubMed 3378566Bijur PE, Schechter C, Esses D, Chang AK, Gallagher EJ. Intravenous bolus of ultra-low-dose naloxone added to morphine does not enhance analgesia in emergency department patients. J Pain. 2006 Feb;7(2):75-81. doi: 10.1016/j.jpain.2005.08.008.
PubMed 16459272Birnbaum A, Esses D, Bijur PE, Holden L, Gallagher EJ. Randomized double-blind placebo-controlled trial of two intravenous morphine dosages (0.10 mg/kg and 0.15 mg/kg) in emergency department patients with moderate to severe acute pain. Ann Emerg Med. 2007 Apr;49(4):445-53, 453.e1-2. doi: 10.1016/j.annemergmed.2006.06.030. Epub 2006 Sep 15.
PubMed 16978739Chang AK, Bijur PE, Baccelieri A, Gallagher EJ. Efficacy and safety profile of a single dose of hydromorphone compared with morphine in older adults with acute, severe pain: a prospective, randomized, double-blind clinical trial. Am J Geriatr Pharmacother. 2009 Feb;7(1):1-10. doi: 10.1016/j.amjopharm.2009.02.002.
PubMed 19281935Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, Bouter LM, de Vet HC. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine (Phila Pa 1976). 2008 Jan 1;33(1):90-4. doi: 10.1097/BRS.0b013e31815e3a10.
PubMed 18165753Girardi C, Duronio J, Patton R, O'Brien K, Clemens S, Brewer KL. A novel opioid/pramipexole combination treatment for the management of acute pain: a pilot study. Front Pain Res (Lausanne). 2024 Sep 24;5:1422298. doi: 10.3389/fpain.2024.1422298. eCollection 2024.
PubMed 39411383
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Treatment With Pramipexole to Reduce the Dose of Opioids Necessary for Analgesia in Acute Renal Colic
- ClinicalTrials.gov ID
- NCT04160520
- Acronym / sponsor ID
- ECarolinaUniversity
- Conditions
- Renal Colic
- Keywords
- morphine, Pramipexole, Renal Colic, Kidney Stone, opioids, analgesia, pain relief
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 24 Jan 2023 (actual)
- Study completion
- 24 Jan 2023 (actual)
- First posted
- 13 Nov 2019 (actual)
- 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.
Opioid analgesics are among the most commonly prescribed class of medications in the US. While opioids may effectively control pain and other sensory disorders under acute conditions, the rates of misuse/abuse and accidental overdose have reached epidemic proportions. Clinicians are being challenged to find alternatives to opioid analgesics, or to reduce their use in treating pain whenever possible. Pre-clinical studies have shown that combining morphine (opioid drug) with pramipexole (dopamine 3 receptor agonist with some D2/D4 action) provides superior analgesia against painful stimuli than morphine alone. This analgesia is maintained even when the dose of morphine is lowered to a dose that is not effective on its own. A recent case report describes the use of this combination to restore pain control in a patient with restless legs syndrome, for which opioids alone have lost their effectiveness (Happe S, Clemens S and Brewer KL, In Review). This application proposes to establish a new therapeutic approach for treatment of a pain associated with renal colic (a common painful condition) using a novel combination of 2 existing, FDA-approved drugs. The immediate goal is to demonstrate that this drug combination can provide similar analgesia to opioid alone, and that analgesia is maintained when the opioid dose is reduced by 50%.
Detailed description
This is a double-blinded randomized controlled trial to take place in the Vidant Medical Center (VMC) Emergency Department (ED). A convenience sample of 96 participants will be drawn from patients presenting to the ED presentation with pain associated with suspected renal colic who do not experience pain relief after initial treatment with nonsteroidal anti-inflammatories.
Written informed consent will be sought by a study team member after screening to ensure all inclusion criteria and no exclusion criteria are met. Once a patient has consented, they will be randomized into 1 of 2 study arms: Arm 1 (Control arm) = 0.1mg/kg of intravenous morphine + placebo pill, single dose Arm 2 (Study arm) = 0.05mg/kg intravenous morphine + 0.25mg pramipexole, single dose. Both arms include a maximum dose of 10mg/kg for the IV morphine. Pain scores will be obtained prior to administration of study drugs, and at 15-minute intervals (+/- 2 mins) after treatment for up to 2 hours, or discharge from the ED. Subjective response to each drug treatment will also be assessed every 15 minutes (+/- 2 mins) after treatment for up to 2 hours, or discharge from ED. Morphine will have a max dose of 10mg IV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pramipexole and half-standard dose of morphine | Experimental | Drug: Pramipexole, Drug: Morphine0.25 mg oral tablet of pramipexole in combination with 0.05mg/kg of IV morphine |
| Standard dose of morphine and placebo | Active comparator | Drug: Morphine, Drug: Placebo oral tablet0.1mg/kg of IV morphine in combination with a placebo pill |
Who may qualify
- Ages
- 19 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 19 - 65
- ED presentation with pain associated with suspected renal colic
- Patient reported failure to achieve pain relief with NSAID treatment in ED (additional pain treatment needed per treatment team)
Key exclusion criteria (8 listed)
- Age < 19 or ≥ 66
- Allergy to any study medication
- Known pregnancy or breastfeeding
- Received opioid prior to enrollment
- Received IV Lidocaine during current ED visit
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 |
|---|---|---|
| PramipexoleEstablish proof of concept that low dose morphine in combination with pramipexole is non-inferior to standard dose morphine with respect to providing analgesia in patients presenting to the ED with pain associated with renal colic. | Drug | Pramipexole and half-standard dose of morphine |
| MorphineEstablish proof of concept that low dose morphine in combination with pramipexole is non-inferior to standard dose morphine with respect to providing analgesia in patients presenting to the ED with pain associated with renal colic. | Drug | Pramipexole and half-standard dose of morphine, Standard dose of morphine and placebo |
| Placebo oral tabletEstablish proof of concept that low dose morphine in combination with pramipexole is non-inferior to standard dose morphine with respect to providing analgesia in patients presenting to the ED with pain associated with renal colic. | Drug | Standard dose of morphine and placebo |
Primary outcome
Proportion of patients who have an effective analgesic response (defined as at least a 50% improvement in pain scores) at 120 minutes post-randomization.
Time frame: 120 minutes
Pain scores used are the numerical rating scale (0 low to 10 high) or visual analogue scale (0 low to 100mm high).
Total dose of opioid received at 120 minutes in patients reporting a reduction in pain scores from baseline.
Time frame: 120 minutes
Dose of opioid measured in mg/kg
Proportion of patients who require rescue medications at 30 minutes post-randomization.
Time frame: 30 minutes
2 secondary outcomes
Time to reach effective pain reduction (defined as at least a 50% improvement in pain scores) within 120 minutes of treatment.
Time frame: 120 minutes
Subjective effects of the drugs measured by scores on the drug effects questionnaire.
Time frame: 120 minutes
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 8 Mar 2023.
- Background: PubMed 30910641Rodgers HM, Yow J, Evans E, Clemens S, Brewer KL. Dopamine D1 and D3 receptor modulators restore morphine analgesia and prevent opioid preference in a model of neuropathic pain. Neuroscience. 2019 May 15;406:376-388. doi: 10.1016/j.neuroscience.2019.03.034. Epub 2019 Mar 23.
- Background: PubMed 26120804Afshar K, Jafari S, Marks AJ, Eftekhari A, MacNeily AE. Nonsteroidal anti-inflammatory drugs (NSAIDs) and non-opioids for acute renal colic. Cochrane Database Syst Rev. 2015 Jun 29;2015(6):CD006027. doi: 10.1002/14651858.CD006027.pub2.
- Background: PubMed 29299773Pathan SA, Mitra B, Bhutta ZA, Qureshi I, Spencer E, Hameed AA, Nadeem S, Tahir R, Anjum S, Cameron PA. A comparative, epidemiological study of acute renal colic presentations to emergency departments in Doha, Qatar, and Melbourne, Australia. Int J Emerg Med. 2018 Jan 3;11(1):1. doi: 10.1186/s12245-017-0160-9.
- Background: PubMed 20978218Patanwala AE, Keim SM, Erstad BL. Intravenous opioids for severe acute pain in the emergency department. Ann Pharmacother. 2010 Nov;44(11):1800-9. doi: 10.1345/aph.1P438. Epub 2010 Oct 26.
- Background: PubMed 25894754Altun A, Yildirim K, Ozdemir E, Bagcivan I, Gursoy S, Durmus N. Attenuation of morphine antinociceptive tolerance by cannabinoid CB1 and CB2 receptor antagonists. J Physiol Sci. 2015 Sep;65(5):407-15. doi: 10.1007/s12576-015-0379-2. Epub 2015 Apr 18.
- Background: PubMed 26374993Altun A, Ozdemir E, Yildirim K, Gursoy S, Durmus N, Bagcivan I. The effects of endocannabinoid receptor agonist anandamide and antagonist rimonabant on opioid analgesia and tolerance in rats. Gen Physiol Biophys. 2015 Oct;34(4):433-40. doi: 10.4149/gpb_2015017.
- Background: PubMed 16527399Terner JM, Barrett AC, Lomas LM, Negus SS, Picker MJ. Influence of low doses of naltrexone on morphine antinociception and morphine tolerance in male and female rats of four strains. Pain. 2006 May;122(1-2):90-101. doi: 10.1016/j.pain.2006.01.019. Epub 2006 Mar 9.
- Background: PubMed 3378566Dourish CT, Hawley D, Iversen SD. Enhancement of morphine analgesia and prevention of morphine tolerance in the rat by the cholecystokinin antagonist L-364,718. Eur J Pharmacol. 1988 Mar 15;147(3):469-72. doi: 10.1016/0014-2999(88)90183-5.
- Background: PubMed 16459272Bijur PE, Schechter C, Esses D, Chang AK, Gallagher EJ. Intravenous bolus of ultra-low-dose naloxone added to morphine does not enhance analgesia in emergency department patients. J Pain. 2006 Feb;7(2):75-81. doi: 10.1016/j.jpain.2005.08.008.
- Background: PubMed 16978739Birnbaum A, Esses D, Bijur PE, Holden L, Gallagher EJ. Randomized double-blind placebo-controlled trial of two intravenous morphine dosages (0.10 mg/kg and 0.15 mg/kg) in emergency department patients with moderate to severe acute pain. Ann Emerg Med. 2007 Apr;49(4):445-53, 453.e1-2. doi: 10.1016/j.annemergmed.2006.06.030. Epub 2006 Sep 15.
- Background: PubMed 19281935Chang AK, Bijur PE, Baccelieri A, Gallagher EJ. Efficacy and safety profile of a single dose of hydromorphone compared with morphine in older adults with acute, severe pain: a prospective, randomized, double-blind clinical trial. Am J Geriatr Pharmacother. 2009 Feb;7(1):1-10. doi: 10.1016/j.amjopharm.2009.02.002.
- Background: PubMed 18165753Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, Bouter LM, de Vet HC. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine (Phila Pa 1976). 2008 Jan 1;33(1):90-4. doi: 10.1097/BRS.0b013e31815e3a10.
- 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.
Kori Brewer, PhD principal investigator
East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pramipexole and Morphine in people with Renal Colic, run by East Carolina University at 1 site 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 3 inclusion and 8 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 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
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?
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?
Proportion of patients who have an effective analgesic response (defined as at least a 50% improvement in pain scores) at 120 minutes post-randomization. (time frame: 120 minutes). The study lists 3 primary outcomes in all. 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 NCT04160520, which also lists 13 linked publications.
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 8 Mar 2023.