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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
Awards & highlights

Study Summary

This trial will test if a new drug is effective and safe. Half the participants will receive the drug and half will receive a placebo. The trial is double-blind, meaning neither the participants nor the researchers will know who is receiving the drug or the placebo.

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.Check my eligibility
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.See study design
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
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I am between 18 and 55 years old.
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I can speak and understand either English or Spanish.
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I am not able to have children or I agree to use birth control.
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I am a man who is either surgically sterile or will use birth control.

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
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Secondary outcome measures
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

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.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

South Rampart Pharma, LLCLead Sponsor
Hernan A Bazan, MDStudy ChairCEO
~19 spots leftby Jun 2025
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