What is the mechanism of action of this treatment?

Common pain treatments work through various mechanisms to alleviate pain. NSAIDs reduce inflammation and pain by inhibiting cyclooxygenase enzymes (COX-1 and COX-2), which are involved in the production of prostaglandins. Acetaminophen, though not fully understood, is believed to reduce pain by acting on the central nervous system and inhibiting the synthesis of prostaglandins in the brain. Opioids bind to opioid receptors in the brain and spinal cord, blocking pain signals. Antidepressants, particularly those affecting serotonin and norepinephrine, can modulate pain perception by altering neurotransmitter levels. Non-pharmacologic treatments like CBT help patients manage pain by changing their pain-related thoughts and behaviors, while manual therapies may work through descending modulation to reduce pain. Understanding these mechanisms is essential for optimizing pain management and improving patient outcomes.

What side effects are associated with this type of intervention?

Common treatments for pain, such as NSAIDs and acetaminophen, can cause gastrointestinal issues, liver toxicity, and renal impairment. Antidepressants used for pain management may lead to dry mouth, weight gain, and drowsiness. Opioids, while effective for severe pain, carry risks of constipation, nausea, sedation, and potential for addiction and misuse. Non-pharmacological interventions generally have fewer adverse effects but require more rigorous trials to confirm their safety and efficacy.

What prior FDA approvals exist?

The FDA has approved several categories of drugs for the treatment of pain. Common analgesics include acetaminophen and NSAIDs like ibuprofen and naproxen, which are often used for acute pain management. Cannabinoid-based drugs, such as nabiximols, have been approved in some countries for specific types of pain, though their approval in the U.S. is limited. There is also ongoing research into the efficacy and safety of these treatments, particularly in pediatric and cancer-related pain management. Despite these approvals, there are still gaps in the evidence, especially regarding long-term use and multimodal pain treatment strategies.

What other types of research exist?

Promising novel alternatives for pain management in 2024 include: 1) Sulodexide, which has shown potential in reducing hospitalizations and the need for supplemental oxygen in COVID-19 patients, indicating its anti-inflammatory and anticoagulant properties may be beneficial for pain management. 2) Cannabinoid-based therapies, such as nabiximols, which have shown some efficacy in chronic pain management, particularly neuropathic pain. 3) Tanezumab and fasinumab, which are nerve growth factor inhibitors being investigated for osteoarthritis pain. 4) JAK inhibitors like upadacitinib and tofacitinib, which are being studied for their efficacy in conditions like ankylosing spondylitis. These alternatives represent a range of mechanisms and therapeutic targets that could offer new options for pain patients.

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SRP-3D for Pain Management

Phase 1

Waitlist Available

Research Sponsored by South Rampart Pharma, LLC

Eligibility Criteria Checklist

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

Must have

Is between 18 and 55 years of age (inclusive).

Able to speak and understand English or Spanish.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the time of providing written informed consent until 30 days after the last dose of study drug

Summary

This trial tests a new drug called SRP-3D (DA) in a general study group. It aims to gather information on safety and how the drug behaves in the body.

Who is the study for?

This trial is for healthy men and women aged 18-55 who are not pregnant or breastfeeding. Participants must understand English or Spanish, have a BMI of 18-32, agree to use birth control if applicable, and commit to the study schedule including inpatient stays and outpatient visits.

What is being tested?

The study tests SRP-3D (diethylamide), a new drug for pain relief. It's compared with a placebo in two parts: single ascending dose (SAD) and multiple ascending dose (MAD). The process is randomized and double-blind, meaning neither participants nor researchers know who gets the real drug.

What are the potential side effects?

Potential side effects aren't specified here but typically include reactions at varying degrees such as headaches, nausea, dizziness or fatigue. Since it's a blinded trial for safety assessment, close monitoring will occur.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 55 years old.

Select...

I can speak and understand either English or Spanish.

Select...

I am not able to have children or I agree to use birth control.

Select...

I am a man who is either surgically sterile or will use birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the time of providing written informed consent until 30 days after the last dose of study drug

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the time of providing written informed consent until 30 days after the last dose of study drug

This trial's timeline: 3 weeks for screening, Varies for treatment, and the time of providing written informed consent until 30 days after the last dose of study drug 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 participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary study objectives

PK parameters

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ExperimentalExperimental Treatment1 Intervention

SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL

Group II: PlaceboPlacebo Group1 Intervention

Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL

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

Common pain treatments work through various mechanisms to alleviate pain. NSAIDs reduce inflammation and pain by inhibiting cyclooxygenase enzymes (COX-1 and COX-2), which are involved in the production of prostaglandins. Acetaminophen, though not fully understood, is believed to reduce pain by acting on the central nervous system and inhibiting the synthesis of prostaglandins in the brain. Opioids bind to opioid receptors in the brain and spinal cord, blocking pain signals. Antidepressants, particularly those affecting serotonin and norepinephrine, can modulate pain perception by altering neurotransmitter levels. Non-pharmacologic treatments like CBT help patients manage pain by changing their pain-related thoughts and behaviors, while manual therapies may work through descending modulation to reduce pain. Understanding these mechanisms is essential for optimizing pain management and improving patient outcomes.

Challenges and opportunities in translational pain research - An opinion paper of the working group on translational pain research of the European pain federation (EFIC).The Role of Descending Modulation in Manual Therapy and Its Analgesic Implications: A Narrative Review.