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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy adult
Is 18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights
Summary
This trial is testing a new topical gel called BAYH006689 for muscle and joint pain. The researchers want to see if applying this gel on the skin causes any skin reactions in healthy participants.
Who is the study for?
This trial is for healthy individuals who will have a topical gel applied to their skin. Participants should not expect personal health benefits from the study but will contribute to research on treating muscle and joint pain.
What is being tested?
The study tests BAYH006689, a new topical gel for muscle and joint pain, against a placebo (no active medicine) and saline solution. It aims to see if the gel causes skin reactions when applied below the shoulder blades three times weekly over several weeks.
What are the potential side effects?
Potential side effects may include skin reactions at the application site such as redness, swelling, itching or irritation. Serious body-wide side effects are considered uncommon with this type of medication.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a healthy adult.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Skin sensitization potential
Side effects data
From 2014 Phase 4 trial • 323 Patients • NCT015872746%
Nausea/ vomiting
5%
Stomach irritation
4%
Dizziness
4%
Drowsiness
3%
Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Naproxen Alone
Opioid
Skeletal Muscle Relaxant
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: BAYHO06689Experimental Treatment1 Intervention
Topical application of BAYH006689 naproxen 10% topical gel on the intact skin
Group II: PlaceboPlacebo Group1 Intervention
Topical application of placebo gel which contains 0% of naproxen on the intact skin
Group III: Negative controlPlacebo Group1 Intervention
Topical application of the sterile 0.9% saline (negative control) on the intact skin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naproxen (BAYH006689)
2024
Completed Phase 1
~240
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
BayerLead Sponsor
2,260 Previous Clinical Trials
25,309,209 Total Patients Enrolled
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