Suzetrigine for Acute Pain

Recruiting at 11 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Vertex Pharmaceuticals Incorporated

Disqualifiers: Previous Suzetrigine, Journavx, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate the effectiveness, safety, and tolerability of SUZ for acute pain after laparoscopic procedures of the intraperitoneal or retroperitoneal cavities or arthroscopic orthopedic procedures.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What safety data exists for Suzetrigine in humans?

The research articles provided do not contain specific safety data for Suzetrigine or its evaluation under different names for any conditions. ^{1 2 3 4 5}

How does the drug Suzetrigine differ from other treatments for acute pain?

Suzetrigine may offer a unique approach to acute pain management by potentially combining mechanisms seen in drugs like suprofen, which inhibits prostaglandin synthesis, and lamotrigine, which has shown effectiveness in reducing pain through neuronal sensitization inhibition. This could provide a novel option compared to traditional NSAIDs and opioids. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults who've had certain laparoscopic procedures within the intraperitoneal or retroperitoneal cavities, or arthroscopic orthopedic surgeries. Participants must have a BMI between 18.0 and 40.0 kg/m^2.

Inclusion Criteria

My BMI is between 18.0 and 40.0.

I have had a laparoscopic surgery in my abdomen or behind the abdomen.

I am scheduled for or have had a minimally invasive joint surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Suzetrigine (SUZ) for acute pain management for 14 days or until pain resolves

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Suzetrigine

Trial Overview The study is testing Suzetrigine (SUZ) to see how effective and safe it is in managing acute pain following specific minimally invasive surgeries like laparoscopy or arthroscopy.

How Is the Trial Designed?

Group I: Suzetrigine (SUZ) Experimental Treatment 1 Intervention

Participants will receive SUZ for 14 days or until their pain resolves, whichever occurs first.

Who Is Running the Clinical Trial?

Vertex Pharmaceuticals Incorporated

Lead Sponsor

Trials

267

Recruited

36,100+

Dr. David Altshuler

Vertex Pharmaceuticals Incorporated

Chief Medical Officer since 2020

MD, PhD

Dr. Reshma Kewalramani

Vertex Pharmaceuticals Incorporated

Chief Executive Officer since 2020

MD, trained in internal medicine and nephrology

Published Research Related to This Trial

A systematic review of 80 randomized controlled trials (RCTs) on noninvasive analgesic treatments revealed that adverse event (AE) reporting was often incomplete, with over 40% of trials not reporting any serious adverse events.

The review highlighted that trials involving participants with pain conditions and those sponsored by industry provided better AE data, indicating a need for improved consistency and thoroughness in AE reporting across all analgesic RCTs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations. Smith, SM., Wang, AT., Katz, NP., et al.[2023]

A systematic review of nonpharmacologic pain treatment trials revealed significant inadequacies in adverse event (AE) reporting, with less than half of the trials detailing specific AE assessment methods.

AE reporting was more comprehensive in trials involving patients compared to those with healthy volunteers, indicating a need for improved adherence to reporting guidelines across all types of trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting in nonpharmacologic, noninterventional pain clinical trials: ACTTION systematic review. Hunsinger, M., Smith, SM., Rothstein, D., et al.[2018]

Opioids can be effective and relatively safe options for managing pain, but they are often avoided due to concerns about potential side effects and adverse events.

The side effects of opioids can affect multiple body systems, but with proper management and quick intervention, these effects can be addressed, allowing opioids to be used safely and effectively for pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticipating and treating opioid-associated adverse effects. Herndon, CM., Kalauokalani, DA., Cunningham, AJ., et al.[2019]

A review of 10 randomized controlled trials on acupuncture for pain relief found that only 6 studies reported adverse events, and most did not adequately detail how these events were collected or assessed.

The findings indicate that acupuncture trials have not fully adhered to the updated CONSORT guidelines for reporting adverse events, highlighting the need for improved documentation to ensure patient safety and better understanding of potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting in acupuncture clinical trials focusing on pain. Capili, B., Anastasi, JK., Geiger, JN.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Adverse event reporting in nonpharmacologic, noninterventional pain clinical trials: ACTTION systematic review. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Anticipating and treating opioid-associated adverse effects. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Adverse event reporting in acupuncture clinical trials focusing on pain. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Suprofen. An overview of long-term safety. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Mechanism of action of suprofen, a new peripheral analgesic, as demonstrated by its effects on several nociceptive mediators. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of lamotrigine in the acute and chronic hyperalgesia induced by PGE2 and in the chronic hyperalgesia in rats with streptozotocin-induced diabetes. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Current concepts in acute pain management. [2004]

9. United States pubmed.ncbi.nlm.nih.gov

Clinical effectiveness of lamotrigine and plasma levels in essential and symptomatic trigeminal neuralgia. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Antinociception induced by SM 32 depends on a central cholinergic mechanism. [2019]