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lidocaine-prilocaine for Pain
Phase 2
Waitlist Available
Led By Cynthia Brincat, MD
Research Sponsored by Loyola University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up removal of pessary
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Summary
The purpose of this study is to evaluate if lidocaine-prilocaine (EMLA 5%) cream can reduce pain and discomfort at the time of vaginal pessary removal and insertion. Half of the participants will receive lidocaine-prilocaine (EMLA 5%) cream and the other half will receive a placebo cream.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ removal of pessary
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~removal of pessary
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain
Secondary study objectives
VAS Score at the Time of Pessary Insertion Adjusting for Baseline Pain
VAS Score at the Time of Pessary Removal Adjusting for Baseline Pain and Patient Age
VAS Score at the Time of Pessary Removal Adjusting for Pessary Type and Investigator Training
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: lidocaine-prilocaineExperimental Treatment1 Intervention
4 mL of lidocaine-prilocaine cream
Group II: PlaceboPlacebo Group1 Intervention
4 mL of placebo cream
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prilocaine
FDA approved
Find a Location
Who is running the clinical trial?
Loyola UniversityLead Sponsor
160 Previous Clinical Trials
31,402 Total Patients Enrolled
4 Trials studying Pain
213 Patients Enrolled for Pain
Cynthia Brincat, MDPrincipal InvestigatorLoyola University
3 Previous Clinical Trials
311 Total Patients Enrolled
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