What side effects are associated with this type of intervention?

Common treatments for acute pain include NSAIDs, opioids, and other analgesics. NSAIDs, such as ibuprofen and diclofenac, can cause gastrointestinal issues like ulcers and bleeding, renal impairment, and cardiovascular risks. Opioids, including morphine and codeine, are associated with side effects such as nausea, vomiting, constipation, drowsiness, and the potential for dependence and respiratory depression. Other analgesics like acetaminophen are generally well-tolerated but can lead to liver damage if used in excessive doses. It is important to use these medications under medical supervision to manage side effects effectively.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of acute pain, including various formulations of sumatriptan for migraine attacks, such as oral, intranasal, and subcutaneous routes. Additionally, non-opioid analgesics like NSAIDs and acetaminophen are commonly used for acute pain management. For more severe pain, opioids and combination drugs like sumatriptan-naproxen have been approved. These treatments aim to provide rapid relief and are tailored to the specific type and severity of pain experienced by patients.

What other types of research exist?

Promising novel alternatives for acute pain management include transdermal buprenorphine, which has shown efficacy and tolerability in chronic pain management, and controlled-release morphine suppositories, which have demonstrated clinical efficacy and safety. Additionally, non-opioid options such as acetyl-L-carnitine for neuropathic pain and sulodexide for COVID-19 related symptoms may offer new avenues for pain relief. These alternatives should be considered in consultation with a healthcare provider to determine the best individualized treatment plan.

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Unknown

SBS-1000 for Safety Evaluation in Healthy Adults

Phase 1

Recruiting

Research Sponsored by Sparian Biosciences, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Minimum body weight of at least 50.0 kg at Screening

Healthy adult male or female, aged 18 to 59 years, inclusive, at Screening

Must not have

Has a current medical condition that would affect sensitivity to cold or pain

Routine or chronic use of acetaminophen and/or nonsteroidal anti-inflammatory drugs (NSAIDs)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of infusion to 72 hours post-infusion

Summary

This trial is testing a new drug called SBS-1000. It involves a group of healthy individuals to find a safe amount to use. Researchers will collect blood and urine samples to see how the drug moves through and affects the body.

Who is the study for?

Healthy adults aged 18-59, weighing at least 50 kg with a BMI of 18-33 can join this trial. They must not smoke, have no significant health issues, and agree to use contraception. Those with recent illnesses or on prescription drugs cannot participate.

What is being tested?

The study is testing SBS-1000's safety and how well it's tolerated when given intravenously compared to a placebo in healthy volunteers. It's conducted in phases where doses are increased gradually.

What are the potential side effects?

Since SBS-1000 is being tested for the first time in humans, potential side effects are unknown but may include typical drug reactions like pain at injection site, nausea, headache, or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I weigh at least 50 kg.

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I am a healthy adult between 18 and 59 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition that affects how I feel cold or pain.

Select...

I regularly use acetaminophen or NSAIDs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of infusion to 72 hours post-infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of infusion to 72 hours post-infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of infusion to 72 hours post-infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of subjects with adverse events (AEs)

Secondary study objectives

Area under the plasma concentration (AUC) and Cmax versus time curve of SBS-1000

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: SBS-1000Active Control1 Intervention

Investigational Product

Group II: PlaceboPlacebo Group1 Intervention

Normal saline (0.9% sodium chloride \[NaCl\])

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for acute pain include NSAIDs, acetaminophen, opioids, and intravenous agents like dihydroergotamine. NSAIDs reduce inflammation and pain by inhibiting cyclooxygenase enzymes, while acetaminophen likely works through central inhibition of prostaglandin synthesis. Opioids alter pain perception by binding to opioid receptors in the brain and spinal cord. Intravenous agents like dihydroergotamine act on serotonin receptors to constrict blood vessels and reduce inflammation. Understanding these mechanisms helps in selecting the most appropriate treatment based on the pain's origin, severity, and patient-specific factors.

The Role of Descending Modulation in Manual Therapy and Its Analgesic Implications: A Narrative Review.