OliceridinePhase 4NCT06619145
1.Comparison of the Analgesic Effect of Remifentanil Group and Different Dose Groups of Oliceridine in Postoperative Patients Undergoing Cardiac Surgery 2.Exploring the Hemodynamic Effects of Analgesic Regimens With Different Doses of Oliceridine After Cardiac Surgery
A Phase 4 study testing Low dose Oliceridine and High dose Oliceridine in people with Oliceridine and Postoperative Cardiac Surgery, run by Nanjing First Hospital, Nanjing Medical University at 2 sites in China.
Trial summary
Cardiac surgery has the characteristics of long duration and large amount of intraoperative bleeding, easy to involve multiple organs and severe tissue injury, which is one of the most serious surgical procedures with postoperative pain and the incidence of postoperative pain after open-heart surgery is as high as… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oliceridine, Postoperative Cardiac Surgery
- What is being tested?
- Low dose Oliceridine and High dose Oliceridine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 2 sitesChina
- Study dates
- 1 Nov 2024to 30 Oct 2026
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Postoperative patients undergoing cardiac surgery from November 2024 to October 2025
Who cannot join
- body mass index (BMI) \> 35 kg/m2 or weight \< 40 kg; ② age \< 18 years old, or ≥ 80 years old; ③ sleep apnea; ④ opioid allergy; ⑤ use of analgesic drugs for chronic pain; ⑥ prolongation of the Q-T interval; ⑦ serious dysfunction of the liver and kidneys and other organs; ⑧ the presence of postoperative low cardiac output, hemorrhage, vascular paralysis syndrome, etc. Causes circulatory disorders.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Xiong Shengnan Nanjing. Frst hospital, 8618460306119, 18460306119@163.com
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Xiong shengnan Nanjing first Hospital, 8618460306119, 18460306119@163.com
About this study
Official title: Oliceridine for Analgesia After Cardiac Surgery
Cardiac surgery has the characteristics of long duration and large amount of intraoperative bleeding, easy to involve multiple organs and severe tissue injury, which is one of the most serious surgical procedures with postoperative pain and the incidence of postoperative pain after open-heart surgery is as high as 50%, with the incidence of moderate-to-severe pain ranging from 3% to 18% . Currently, opioids are commonly used in clinical practice for postoperative cardiac analgesia, but due to the abnormal cardiac structure of cardiac surgery patients, surgery and extracorporeal circulation effects, hemodynamic fluctuations and respiratory depression, nausea and vomiting, dizziness, constipation, and other adverse reactions occur during analgesia [3]. Therefore, it is especially necessary to find an analgesic drug with good analgesic effect and able to reduce such adverse effects.
Oliceridine is a G-protein biased μ-opioid receptor agonist, which selectively activates the G-protein signaling pathway and significantly reduces the activation of the β-inhibitory protein pathway, preserving the analgesic effect while reducing the opioid-related adverse effects, and is currently used for intraoperative analgesia and analgesic treatment of acute moderate-to-severe pain occurring after surgery such as abdominal surgery and bunion bursitis, and is mostly administered by a single injection into the vein .A series of national and international clinical studies have been conducted on OliceridineA phase 1 clinical trial study conducted by Soergel et al. demonstrated that in healthy subjects, 3 and 4.5 mg ofOliceridine demonstrated higher peak analgesia (75 sec latency) compared to morphine. In addition, all doses were associated with lower respiratory drive reductions compared to morphine (- 7.3, - 7.6, and - 9.4 h*L/min vs - 15.9 h*L/min). Respiratory depression persisted with Oliceridine but was very transient, and subjects on the 1.5 mg and 3 mg doses experienced less nausea compared to subjects on the 4.5 mg dose and morphine. Overall, the 3 mg dose provided significant efficacy while still maintaining the reduction in PONV demonstrated by the low dose of choline.
To further investigate the effects of Oliceridine on the respiratory system, Simons et al. conducted a crossover study of 18 healthy elderly volunteers. The study found that while low doses of Oliceridine did not result in any significant respiratory effects, high doses of Oliceridine and two doses of morphine resulted in respiratory depression that peaked 0.5 to 1 hour after administration. However, similar to the earlier findings of Soergel et al, the respiratory depression induced by Oliceridine was more transient, characterized by a more rapid return to baseline, with an equilibrium half-life at the blood effector site of 44.3 ± 6.1 minutes compared with 214 ± 27 minutes for morphine.A subsequent phase III study was also conducted on the use of Oliceridine in the management of moderate to severe acute postoperative pain after abdominoplasty. The results showed that Oliceridine is a safe and effective intravenous analgesic for the relief of moderate to severe acute postoperative pain in patients undergoing abdominoplasty. Since the low-dose regimen of 0.1 mg of oseltamivirine was superior to placebo but not as effective as the morphine regimen, safety comparisons with morphine were only relevant to the 2 isoanalgesic dose groups of 0.35 and 0.5 mg, and oseltamivirine showed a favorable safety profile in terms of respiratory and gastrointestinal adverse effects tolerability compared with morphine. This suggests that Oliceridine may offer a new therapeutic option for patients with moderate to severe acute pain requiring intravenous opioids.Based on the relatively long duration of analgesia in postoperative cardiac surgery patients, there is a need to explore drugs with the advantages of better analgesic effect, less hemodynamic impact, sustained analgesia with fewer adverse effects, and rapid metabolism after discontinuation of the drug. Combining the existing research base of this project and the above domestic and international findings, we propose the conjecture that Oliceridine may provide better analgesia with fewer adverse effects in the postoperative period of cardiac surgery relative to other opioid analgesic drugs. In this study, we propose to study the analgesic effect of different doses of Oliceridine for pumping in postoperative cardiac surgery patients, its effect on hemodynamics and safety assessment, and we intend to expect to determine the optimal dosing regimen for postoperative cardiac analgesia.
- Conditions
- Oliceridine, Postoperative Cardiac Surgery
- Being tested
- Low dose Oliceridine, High dose Oliceridine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose OliceridineDrug
Low dose Oliceridine
High dose OliceridineDrug
High dose Oliceridine
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil | No intervention | Not described |
| High dose Oliceridine | Experimental | High dose Oliceridine Receives: Drug: High dose Oliceridine |
| Low dose Oliceridine | Experimental | Low dose Oliceridine Receives: Drug: Low dose Oliceridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPOT score
Measured: 15 minutes, 30 minutes, 1 hour (h), 4 h, 8 h, 12 h, 24 hours (h) after loading dose drugs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for OliceridineStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619145
- Sponsor's protocol ID
- KY20240924-07
- Status last verified
- Sep 2024
- First submitted
- 27 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singla NK, Skobieranda F, Soergel DG, Salamea M, Burt DA, Demitrack MA, Viscusi ER. APOLLO-2: A Randomized, Placebo and Active-Controlled Phase III Study Investigating Oliceridine (TRV130), a G Protein-Biased Ligand at the mu-Opioid Receptor, for Management of Moderate to Severe Acute Pain Following Abdominoplasty. Pain Pract. 2019 Sep;19(7):715-731. doi: 10.1111/papr.12801. Epub 2019 Jun 24.
PubMed 31162798Viscusi ER, Webster L, Kuss M, Daniels S, Bolognese JA, Zuckerman S, Soergel DG, Subach RA, Cook E, Skobieranda F. A randomized, phase 2 study investigating TRV130, a biased ligand of the mu-opioid receptor, for the intravenous treatment of acute pain. Pain. 2016 Jan;157(1):264-272. doi: 10.1097/j.pain.0000000000000363.
PubMed 26683109Dahan A, van Dam CJ, Niesters M, van Velzen M, Fossler MJ, Demitrack MA, Olofsen E. Benefit and Risk Evaluation of Biased mu-Receptor Agonist Oliceridine versus Morphine. Anesthesiology. 2020 Sep;133(3):559-568. doi: 10.1097/ALN.0000000000003441.
PubMed 32788558Soergel DG, Subach RA, Burnham N, Lark MW, James IE, Sadler BM, Skobieranda F, Violin JD, Webster LR. Biased agonism of the mu-opioid receptor by TRV130 increases analgesia and reduces on-target adverse effects versus morphine: A randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Pain. 2014 Sep;155(9):1829-1835. doi: 10.1016/j.pain.2014.06.011. Epub 2014 Jun 19.
PubMed 24954166Nafziger AN, Arscott KA, Cochrane K, Skobieranda F, Burt DA, Fossler MJ. The Influence of Renal or Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Oliceridine. Clin Pharmacol Drug Dev. 2020 Jul;9(5):639-650. doi: 10.1002/cpdd.750. Epub 2019 Nov 7.
PubMed 31697049Viscusi ER, Skobieranda F, Soergel DG, Cook E, Burt DA, Singla N. APOLLO-1: a randomized placebo and active-controlled phase III study investigating oliceridine (TRV130), a G protein-biased ligand at the micro-opioid receptor, for management of moderate-to-severe acute pain following bunionectomy. J Pain Res. 2019 Mar 11;12:927-943. doi: 10.2147/JPR.S171013. eCollection 2019.
PubMed 30881102Bergese SD, Brzezinski M, Hammer GB, Beard TL, Pan PH, Mace SE, Berkowitz RD, Cochrane K, Wase L, Minkowitz HS, Habib AS. ATHENA: A Phase 3, Open-Label Study Of The Safety And Effectiveness Of Oliceridine (TRV130), A G-Protein Selective Agonist At The micro-Opioid Receptor, In Patients With Moderate To Severe Acute Pain Requiring Parenteral Opioid Therapy. J Pain Res. 2019 Nov 14;12:3113-3126. doi: 10.2147/JPR.S217563. eCollection 2019.
PubMed 31814753Chu F, Yao Y, Gao B, Huang M, Kong L. Incidence and risk factors for potential drug-drug interactions in outpatients receiving opioid analgesics. Expert Opin Drug Saf. 2025 Feb;24(2):167-175. doi: 10.1080/14740338.2024.2346101. Epub 2024 Apr 23.
PubMed 38641999Bjornnes AK, Lie I, Parry M, Falk R, Leegaard M, Rustoen T, Valeberg BT. Association between self-perceived pain sensitivity and pain intensity after cardiac surgery. J Pain Res. 2018 Aug 1;11:1425-1432. doi: 10.2147/JPR.S167524. eCollection 2018.
PubMed 30122973
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oliceridine for Analgesia After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06619145
- Acronym / sponsor ID
- KY20240924-07
- Conditions
- Oliceridine, Postoperative Cardiac Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 1 Oct 2024 (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.
Cardiac surgery has the characteristics of long duration and large amount of intraoperative bleeding, easy to involve multiple organs and severe tissue injury, which is one of the most serious surgical procedures with postoperative pain and the incidence of postoperative pain after open-heart surgery is as high as 50%, with the incidence of moderate-to-severe pain ranging from 3% to 18% . Currently, opioids are commonly used in clinical practice for postoperative cardiac analgesia, but due to the abnormal cardiac structure of cardiac surgery patients, surgery and extracorporeal circulation effects, hemodynamic fluctuations and respiratory depression, nausea and vomiting, dizziness, constipation, and other adverse reactions occur during analgesia [3]. Therefore, it is especially necessary to find an analgesic drug with good analgesic effect and able to reduce such adverse effects.
Oliceridine is a G-protein biased μ-opioid receptor agonist, which selectively activates the G-protein signaling pathway and significantly reduces the activation of the β-inhibitory protein pathway, preserving the analgesic effect while reducing the opioid-related adverse effects, and is currently used for intraoperative analgesia and analgesic treatment of acute moderate-to-severe pain occurring after surgery such as abdominal surgery and bunion bursitis, and is mostly administered by a single injection into the vein .A series of national and international clinical studies have been conducted on OliceridineA phase 1 clinical trial study conducted by Soergel et al. demonstrated that in healthy subjects, 3 and 4.5 mg ofOliceridine demonstrated higher peak analgesia (75 sec latency) compared to morphine. In addition, all doses were associated with lower respiratory drive reductions compared to morphine (- 7.3, - 7.6, and - 9.4 h*L/min vs - 15.9 h*L/min). Respiratory depression persisted with Oliceridine but was very transient, and subjects on the 1.5 mg and 3 mg doses experienced less nausea compared to subjects on the 4.5 mg dose and morphine. Overall, the 3 mg dose provided significant efficacy while still maintaining the reduction in PONV demonstrated by the low dose of choline.
To further investigate the effects of Oliceridine on the respiratory system, Simons et al. conducted a crossover study of 18 healthy elderly volunteers. The study found that while low doses of Oliceridine did not result in any significant respiratory effects, high doses of Oliceridine and two doses of morphine resulted in respiratory depression that peaked 0.5 to 1 hour after administration. However, similar to the earlier findings of Soergel et al, the respiratory depression induced by Oliceridine was more transient, characterized by a more rapid return to baseline, with an equilibrium half-life at the blood effector site of 44.3 ± 6.1 minutes compared with 214 ± 27 minutes for morphine.A subsequent phase III study was also conducted on the use of Oliceridine in the management of moderate to severe acute postoperative pain after abdominoplasty. The results showed that Oliceridine is a safe and effective intravenous analgesic for the relief of moderate to severe acute postoperative pain in patients undergoing abdominoplasty. Since the low-dose regimen of 0.1 mg of oseltamivirine was superior to placebo but not as effective as the morphine regimen, safety comparisons with morphine were only relevant to the 2 isoanalgesic dose groups of 0.35 and 0.5 mg, and oseltamivirine showed a favorable safety profile in terms of respiratory and gastrointestinal adverse effects tolerability compared with morphine. This suggests that Oliceridine may offer a new therapeutic option for patients with moderate to severe acute pain requiring intravenous opioids.Based on the relatively long duration of analgesia in postoperative cardiac surgery patients, there is a need to explore drugs with the advantages of better analgesic effect, less hemodynamic impact, sustained analgesia with fewer adverse effects, and rapid metabolism after discontinuation of the drug. Combining the existing research base of this project and the above domestic and international findings, we propose the conjecture that Oliceridine may provide better analgesia with fewer adverse effects in the postoperative period of cardiac surgery relative to other opioid analgesic drugs. In this study, we propose to study the analgesic effect of different doses of Oliceridine for pumping in postoperative cardiac surgery patients, its effect on hemodynamics and safety assessment, and we intend to expect to determine the optimal dosing regimen for postoperative cardiac analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remifentanil | No intervention | – |
| High dose Oliceridine | Experimental | Drug: High dose OliceridineHigh dose Oliceridine |
| Low dose Oliceridine | Experimental | Drug: Low dose OliceridineLow dose Oliceridine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Postoperative patients undergoing cardiac surgery from November 2024 to October 2025
Key exclusion criteria (1 listed)
- body mass index (BMI) \> 35 kg/m2 or weight \< 40 kg; ② age \< 18 years old, or ≥ 80 years old; ③ sleep apnea; ④ opioid allergy; ⑤ use of analgesic drugs for chronic pain; ⑥ prolongation of the Q-T interval; ⑦ serious dysfunction of the liver and kidneys and other organs; ⑧ the presence of postoperative low cardiac output, hemorrhage, vascular paralysis syndrome, etc. Causes circulatory disorders.
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 |
|---|---|---|
| Low dose OliceridineLow dose Oliceridine | Drug | Low dose Oliceridine |
| High dose OliceridineHigh dose Oliceridine | Drug | High dose Oliceridine |
Primary outcome
CPOT score
Time frame: 15 minutes, 30 minutes, 1 hour (h), 4 h, 8 h, 12 h, 24 hours (h) after loading dose drugs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Results publication: PubMed 31162798Singla NK, Skobieranda F, Soergel DG, Salamea M, Burt DA, Demitrack MA, Viscusi ER. APOLLO-2: A Randomized, Placebo and Active-Controlled Phase III Study Investigating Oliceridine (TRV130), a G Protein-Biased Ligand at the mu-Opioid Receptor, for Management of Moderate to Severe Acute Pain Following Abdominoplasty. Pain Pract. 2019 Sep;19(7):715-731. doi: 10.1111/papr.12801. Epub 2019 Jun 24.
- Results publication: PubMed 26683109Viscusi ER, Webster L, Kuss M, Daniels S, Bolognese JA, Zuckerman S, Soergel DG, Subach RA, Cook E, Skobieranda F. A randomized, phase 2 study investigating TRV130, a biased ligand of the mu-opioid receptor, for the intravenous treatment of acute pain. Pain. 2016 Jan;157(1):264-272. doi: 10.1097/j.pain.0000000000000363.
- Results publication: PubMed 32788558Dahan A, van Dam CJ, Niesters M, van Velzen M, Fossler MJ, Demitrack MA, Olofsen E. Benefit and Risk Evaluation of Biased mu-Receptor Agonist Oliceridine versus Morphine. Anesthesiology. 2020 Sep;133(3):559-568. doi: 10.1097/ALN.0000000000003441.
- Results publication: PubMed 24954166Soergel DG, Subach RA, Burnham N, Lark MW, James IE, Sadler BM, Skobieranda F, Violin JD, Webster LR. Biased agonism of the mu-opioid receptor by TRV130 increases analgesia and reduces on-target adverse effects versus morphine: A randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Pain. 2014 Sep;155(9):1829-1835. doi: 10.1016/j.pain.2014.06.011. Epub 2014 Jun 19.
- Results publication: PubMed 31697049Nafziger AN, Arscott KA, Cochrane K, Skobieranda F, Burt DA, Fossler MJ. The Influence of Renal or Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Oliceridine. Clin Pharmacol Drug Dev. 2020 Jul;9(5):639-650. doi: 10.1002/cpdd.750. Epub 2019 Nov 7.
- Results publication: PubMed 30881102Viscusi ER, Skobieranda F, Soergel DG, Cook E, Burt DA, Singla N. APOLLO-1: a randomized placebo and active-controlled phase III study investigating oliceridine (TRV130), a G protein-biased ligand at the micro-opioid receptor, for management of moderate-to-severe acute pain following bunionectomy. J Pain Res. 2019 Mar 11;12:927-943. doi: 10.2147/JPR.S171013. eCollection 2019.
- Results publication: PubMed 31814753Bergese SD, Brzezinski M, Hammer GB, Beard TL, Pan PH, Mace SE, Berkowitz RD, Cochrane K, Wase L, Minkowitz HS, Habib AS. ATHENA: A Phase 3, Open-Label Study Of The Safety And Effectiveness Of Oliceridine (TRV130), A G-Protein Selective Agonist At The micro-Opioid Receptor, In Patients With Moderate To Severe Acute Pain Requiring Parenteral Opioid Therapy. J Pain Res. 2019 Nov 14;12:3113-3126. doi: 10.2147/JPR.S217563. eCollection 2019.
- Results publication: PubMed 38641999Chu F, Yao Y, Gao B, Huang M, Kong L. Incidence and risk factors for potential drug-drug interactions in outpatients receiving opioid analgesics. Expert Opin Drug Saf. 2025 Feb;24(2):167-175. doi: 10.1080/14740338.2024.2346101. Epub 2024 Apr 23.
- Results publication: PubMed 30122973Bjornnes AK, Lie I, Parry M, Falk R, Leegaard M, Rustoen T, Valeberg BT. Association between self-perceived pain sensitivity and pain intensity after cardiac surgery. J Pain Res. 2018 Aug 1;11:1425-1432. doi: 10.2147/JPR.S167524. eCollection 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low dose Oliceridine and High dose Oliceridine in people with Oliceridine and Postoperative Cardiac Surgery, run by Nanjing First Hospital, Nanjing Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu Qiaolian Nanjing First Hospital (8613813392129, xuaqiao1229@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPOT score (time frame: 15 minutes, 30 minutes, 1 hour (h), 4 h, 8 h, 12 h, 24 hours (h) after loading dose drugs). 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 NCT06619145, which also lists 9 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 1 Oct 2024.