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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.
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I agree to stay in the hospital when needed and come back for follow-up visits.

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

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals of age 65 and below accepted in this research endeavor?

"To qualify for this trial, patients must be between the age of 18 and 55. There are 71 studies available to individuals younger than 18 and 247 options for those over 65 years old."

Answered by AI

Has the FDA sanctioned SRP-3D (diethylamide) for clinical use?

"The safety of SRP-3D (diethylamide) is assessed as a 1 on the scale from 1 to 3 due to it being in Phase 1 trials. This indicates that there are only limited data available which attest to its efficacy and security."

Answered by AI

Can I enroll in this trial?

"This clinical trial is seeking 56 individuals, ranging from 18 to 55 years of age and suffering from physical pain. Eligible participants must be male or female; however, females are prohibited from being pregnant or nursing. Furthermore, BMI should fall between 18-32 kg/m2 for inclusion in the study. Additionally, proficiency in either English or Spanish is required as well as agreement with associated testing procedures and confinement periods throughout the research period. Moreover, good health criteria must be met alongside appropriate vital signs at screening visits while non-childbearing potential women have to use contraception methods and men need to demonstrate surgical sterility - if not then they too"

Answered by AI

Are there still openings available for this clinical experiment?

"According to the clinicaltrials.gov database, this trial is open for recruitment and began on January 13th 2023. The most recent update was posted on August 3rd 2022."

Answered by AI

How many participants are partaking in this study?

"Indeed, according to the details on clinicaltrials.gov, recruitment for this trial is ongoing. This research project was initially published on January 13th 2023 and amended most recently in August 3rd 2022. The investigators are looking to enrol 56 patients from a single medical centre."

Answered by AI

Who else is applying?

What state do they live in?
New York
Florida
How old are they?
18 - 65
What site did they apply to?
Quotient Sciences-Miami, Inc.
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Phone Call
Most responsive sites:
  1. Quotient Sciences-Miami, Inc.: < 24 hours
~20 spots leftby Mar 2025