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Loxoprofen Pain Patch

Phase 2

Delayed Onset Muscle Soreness | Small molecule | Other |Cardinal Health, Inc.|Last Updated: Oct 28, 2016

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment42

FDA Designations

No designations recorded

Clinical trial landscape

Loxoprofen Pain Patch · 1 trial · 1 indication

Phase 2 1
NCT02602353Pilot Study Comparing the Efficacy and Safety of a New Pain Patch and Placebo in Delayed Onset Muscle Soreness (DOMS)Delayed Onset Muscle Soreness
COMPLETED42 Analytics
PHASE2COMPLETED
Pilot Study Comparing the Efficacy and Safety of a New Pain Patch and Placebo in Delayed Onset Muscle Soreness (DOMS)
Delayed Onset Muscle Soreness
NCT0260235342
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Study Endpoints

Primary Endpoints

Sum of pain intensity differences over 24 hours from baseline (SPID 24) with movement
0-24 hours

Secondary Endpoints

Sum of pain intensity differences over 24 hours from baseline (SPID 24) at rest
0-24 hours
Sum of pain intensity differences over 48 hours from baseline (SPID 48) with movement
0-48 hours
Sum of pain intensity differences over 48 hours from baseline (SPID 48) at rest
0-48 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Loxoprofen Pain PatchEXPERIMENTALOne Active Pain Patch containing loxoprofen applied once daily for 3 days
Placebo PatchPLACEBO_COMPARATOROne Placebo Patch applied once daily for 3 days
No TreatmentOTHERNo Treatment for 3 days

Interventions

NameTypeDescription
Loxoprofen Pain PatchDRUGOne Loxoprofen Pain Patch (active NSAID) applied once daily for 3 days
Placebo PatchDRUGOne Placebo Patch applied daily for 3 days
No TreatmentDRUGNo Treatment for 3 days
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Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Males or females, 18 to 40 years of age * are in good general health, with a BMI less than or equal to 32, and able to perform the exercise regimen * develops muscle pain/soreness within 24-48 hours of the end of the exercise regimen and have a baseline muscle pain/soreness wi...

Countries:United States
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Frequently asked questions about Loxoprofen Pain Patch

What is Loxoprofen Pain Patch used for?

Loxoprofen Pain Patch is an investigational small molecule drug being studied for the treatment of Delayed Onset Muscle Soreness (DOMS). It is a topical patch formulation of loxoprofen, a nonsteroidal anti-inflammatory drug. The patch is currently in Phase 2 clinical development and has not been approved by the FDA.

Who makes Loxoprofen Pain Patch?

Loxoprofen Pain Patch is being developed by Cardinal Health, Inc. (NYSE: CAH). The company is conducting clinical trials to evaluate the safety and efficacy of this topical pain patch for Delayed Onset Muscle Soreness.

What phase is Loxoprofen Pain Patch in?

Loxoprofen Pain Patch is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. A Phase 2 pilot study has been completed to assess its efficacy and safety compared to placebo in patients with Delayed Onset Muscle Soreness.

What clinical trials is Loxoprofen Pain Patch in?

Loxoprofen Pain Patch has one completed Phase 2 clinical trial, NCT02602353, titled "Pilot Study Comparing the Efficacy and Safety of a New Pain Patch and Placebo in Delayed Onset Muscle Soreness (DOMS)." The trial enrolled 42 participants in the United States and was randomized, double-blind, and placebo-controlled.

How does Loxoprofen Pain Patch work?

Loxoprofen Pain Patch contains loxoprofen, a small molecule nonsteroidal anti-inflammatory drug (NSAID). It is designed to deliver the drug locally through the skin to relieve pain associated with Delayed Onset Muscle Soreness. The patch is applied topically to the affected area.