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Ketoprofen 10%

Phase 3

Sprain | Small molecule | Other |Harrow, Inc.|Last Updated: Sep 27, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment364

FDA Designations

No designations recorded

Clinical trial landscape

Ketoprofen 10% · 1 trial · 3 indications

Phase 3 1
NCT00765700Ketoprofen 10% Cream for Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue InjurySprain
COMPLETED364 Analytics
PHASE3COMPLETED
Ketoprofen 10% Cream for Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury
SprainUnlock trial analytics

Study Endpoints

Primary Endpoints

Assess the efficacy of ketoprofen 10% cream in subjects with acute pain associated with mild to moderate acute soft tissue injury (acute sprain or strain) of upper and lower extremities on the day 3 visit.
7 days

Secondary Endpoints

Assess the safety, tolerability and other parameters of ketoprofen 10% cream in subjects with acute pain associated with mild to moderate acute soft tissue injury of upper and lower extremities.
14 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Ketoprofen 10% CreamACTIVE_COMPARATORTopical Ketoprofen 10% Cream 1gram three times daily for 7 days
PlaceboPLACEBO_COMPARATORTopical placebo cream 1gram three times daily for 7 days

Interventions

NameTypeDescription
Topical Ketoprofen 10% CreamDRUGTopical Administration
Topical Placebo CreamDRUGTopical Administration
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 18 to 70 years of age * Have a diagnosis of uncomplicated acute soft tissue injury of the upper or lower extremity that has occurred within the 72 hours preceding the baseline visit. * The injury site must be accessible to the patient so that he or she can apply the study trea...

Countries:United States
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Frequently asked questions about Ketoprofen 10%

What is Ketoprofen 10% used for?

Ketoprofen 10% is a topical cream being developed for the treatment of pain associated with mild to moderate acute soft tissue injury, including sprains and strains. It is a small molecule drug currently in Phase 3 clinical development.

Who makes Ketoprofen 10%?

Ketoprofen 10% is being developed by Harrow, Inc. (NASDAQ: HROW). The company is conducting clinical trials to evaluate the drug's safety and efficacy for treating pain from acute soft tissue injuries.

What phase is Ketoprofen 10% in?

Ketoprofen 10% is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 3 trial has been completed to assess its use for pain associated with mild to moderate acute soft tissue injury.

What clinical trials is Ketoprofen 10% in?

Ketoprofen 10% has one completed Phase 3 trial, NCT00765700, titled 'Ketoprofen 10% Cream for Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury.' The trial enrolled 364 participants in the United States and was randomized, double-blind, and placebo-controlled.

How does Ketoprofen 10% work?

Ketoprofen 10% is a topical nonsteroidal anti-inflammatory drug (NSAID) that works by reducing inflammation and pain at the site of application. It is applied directly to the skin over the injured area to provide localized relief for acute soft tissue injuries.