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Subcutaneous Infusion of Sterile Saline for Healthy Subjects

Q: Which demographic is considered the most suitable for inclusion in this medical study?

Candidates eligible for this research study must be in good health and aged between 18 to 60 years. The trial has capacity for 32 participants.

Q: What is the upper limit on the number of participants involved in this medical study?

Indeed, the details on clinicaltrials.gov reveal that this research study is currently in search of participants. The trial was initially listed on January 12th, 2024 and the latest update occurred on February 2nd, 2024. They aim to enroll a total of 32 subjects at one designated site.

Q: Are individuals currently able to participate in this research study?

As per clinicaltrials.gov, this investigation is currently seeking suitable participants. It was initially shared on 1/12/2024 and last modified on 2/2/2024.

Q: Does this trial enroll participants who are above the age of eighteen?

Participants in this research must be between 18 and 60 years old. There are currently 74 trials targeting individuals below the age of 18, while there are 401 trials focusing on those above 65 years old.

Phase < 1

Recruiting

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 minutes after completion of the saline solution

Awards & highlights

Study Summary

This trial aims to understand how the size of the needle, amount of fluid injected, and speed of injection affect the pain felt by adult volunteers when receiving a saline infusion under the skin.

Who is the study for?

This trial is for healthy adults with a BMI between 18 and 36 who understand English and test negative for COVID-19. It's designed to help understand pain from subcutaneous infusions, which could inform treatments like those used in infertility.Check my eligibility

What is being tested?

The study tests how different needle sizes, fluid volumes, and infusion rates affect pain when injecting sterile saline under the skin of healthy volunteers. This research may improve comfort during such procedures.See study design

What are the potential side effects?

Since only sterile saline is being infused, side effects are expected to be minimal but may include temporary discomfort or pain at the injection site.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 minutes after completion of the saline infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 minutes after completion of the saline infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 minutes after completion of the saline infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Participant's Pain Intensity as Assessed by Verbal Pain Score (VPS)

Participant's Pain Intensity as Assessed by Visual Analog Scale (VAS) Score

Trial Design

1Treatment groups

Experimental Treatment

Group I: Subcutaneous Infusion of Sterile SalineExperimental Treatment1 Intervention

Participants will receive sterile saline subcutaneous infusion administered into abdomen and/or anterior thigh through various sizes of needles at various volume and rate of delivery at Visit 1.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor

975 Previous Clinical Trials

6,384,341 Total Patients Enrolled

Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC

745 Previous Clinical Trials

3,959,938 Total Patients Enrolled

Frequently Asked Questions

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

Which demographic is considered the most suitable for inclusion in this medical study?

"Candidates eligible for this research study must be in good health and aged between 18 to 60 years. The trial has capacity for 32 participants."

Answered by AI

What is the upper limit on the number of participants involved in this medical study?

"Indeed, the details on clinicaltrials.gov reveal that this research study is currently in search of participants. The trial was initially listed on January 12th, 2024 and the latest update occurred on February 2nd, 2024. They aim to enroll a total of 32 subjects at one designated site."

Answered by AI

Are individuals currently able to participate in this research study?

"As per clinicaltrials.gov, this investigation is currently seeking suitable participants. It was initially shared on 1/12/2024 and last modified on 2/2/2024."

Answered by AI

Does this trial enroll participants who are above the age of eighteen?

"Participants in this research must be between 18 and 60 years old. There are currently 74 trials targeting individuals below the age of 18, while there are 401 trials focusing on those above 65 years old."

Answered by AI