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Topical Medication
Diclofenac Sodium Gel for Healthy Participants
Phase 1
Waitlist Available
Research Sponsored by Amzell
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 day 1 to day 7
Awards & highlights
Study Summary
This trial will compare the effects of two topical medications in healthy participants over 7 days, looking at safety and tolerability.
Who is the study for?
Healthy adults aged 18-65 with a BMI of 18.0-35.0 kg/m^2 can join this trial. Women must not be pregnant, use two forms of birth control if capable of childbearing, and pass pregnancy tests. Participants should have no skin conditions at the treatment site (knee), not smoke or use certain medications before and during the study.Check my eligibility
What is being tested?
The trial is testing how much drug gets into the body from two doses of AMZ001 compared to one dose level of Diclofenac Sodium Gel when applied topically for seven days. It's a crossover study where participants will try all three treatments in different periods to check safety and tolerability.See study design
What are the potential side effects?
While specific side effects are not listed, general risks may include skin irritation at the application site, allergic reactions to ingredients in AMZ001 or Diclofenac Gel, and potential systemic effects like digestive issues or headaches.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to day 7
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 7
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Compare exposure to diclofenac
Secondary outcome measures
Local tolerability
Pharmacokinetic parameter - Cavg
Pharmacokinetic parameter - Cmax
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: AMZ001 Low doseExperimental Treatment1 Intervention
AMZ001 applied once daily for 7 consecutive days
Group II: AMZ001 High doseExperimental Treatment1 Intervention
AMZ001 applied once daily for 7 consecutive days
Group III: Diclofenac Sodium 1% GelActive Control1 Intervention
Reference product applied four-times daily for 7 consecutive days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diclofenac Sodium Gel
2018
Completed Phase 3
~1080
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
AmzellLead Sponsor
2 Previous Clinical Trials
444 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any liver diseases or impaired liver function.I am between 18 and 65 years old and healthy.I am willing to use birth control during the study.I do not have issues like acid reflux or stomach ulcers.I haven't been hospitalized or had major surgery in the last 30 days.I haven't donated or lost a significant amount of blood in the last month.I haven't had a fever or serious infection in the last 2 weeks.My knee area is free of skin issues, wounds, or significant hair.I am capable of becoming pregnant and have negative pregnancy tests.I do not have any cancer other than basal cell, unless it's in the treatment area.I don't have any health conditions or take medications that would make it unsafe for me to join this study.I don't have any skin or long-term illnesses that could affect the study.I am using two forms of birth control or am not able to have children due to surgery or menopause.I am using two forms of birth control or have been surgically sterilized.I do not have any kidney diseases or issues with my kidney function.I haven't used any skin products on the treatment area for a week.I haven't used diclofenac in the last 30 days or during the study.My recent health checks, including heart and blood tests, show no significant issues.I am not allergic to diclofenac, aspirin, Xarelto, coumadin, or NSAIDs.I haven't taken any medication in the last 2 weeks or will need it during the study.I am between 18 and 65 years old and in good health.
Research Study Groups:
This trial has the following groups:- Group 1: Diclofenac Sodium 1% Gel
- Group 2: AMZ001 Low dose
- Group 3: AMZ001 High dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any safety considerations to be aware of when utilizing AMZ001 Low Dose?
"Due to the limited clinical evidence supporting AMZ001 Low dose's safety and efficacy, our team assigned it a score of 1."
Answered by AI
Is the minimum age requirement for this research endeavor younger than 18?
"The necessary age range for this medical study is between 18 and 65. Separately, there are 53 trials open to minors and 376 studies available for senescent adults."
Answered by AI
May I participate in this clinical experiment?
"This clinical trial is selecting 75 participants with healthy backgrounds and who are of legal age. To apply, applicants must be between 18-65 years old."
Answered by AI
How many participants are eligible for inclusion in this trial?
"Affirmative. The clinicaltrials.gov post for this research states that recruitment is currently being conducted; the trial was announced on July 11th 2023 and modified most recently on July 27th 2023. A total of 75 participants must be enrolled from 1 medical centre."
Answered by AI
Is this research project accepting new participants at the moment?
"Affirmative. According to clinicaltrials.gov, the research trial is still in search of its participants, with a total recruitment amount of 75 people from one medical centre. The study was initially uploaded on July 11th 2023 and subsequently revised on July 27th 2023."
Answered by AI
Who else is applying?
What site did they apply to?
TKL Research
What portion of applicants met pre-screening criteria?
Met criteria
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