Transdermal Ketoprofen to Treat Mild to Moderate Osteoart... | NCT00108810

Studies
Transdermal Ketoprofen to Treat Mild to Moderate Osteoarthritis (OA) Pain of the Knee

NCT00108810

Sponsor

ZARS Pharma Inc.

Status

Completed

Last Update Posted

Jun 5, 2012Estimated

Enrollment

118Actual

Phase

Phase 2

Conditions

Pain
Osteoarthritis, Knee

Interventions

Transdermal Ketoprofen Patch with CHADD
Placebo transdermal patch

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

Randomized, Double-Blind, Parallel, Placebo Controlled 4 Week Proof-of-Concept Study to Evaluate the Safety and Efficacy of Transdermal Ketoprofen When Administered With Controlled Heat in Patients With Mild to Moderate OA Pain of the Knee

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2005

Primary Completion Date

Oct 2005Actual

Completion Date

Oct 2005Actual

First Submitted Date

Apr 18, 2005

First Submission Date that Met QC Criteria

Apr 18, 2005

First Posted Date

Apr 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Mar 14, 2012

Certification/Extension First Submitted that Passed QC Review

May 30, 2012

Certification/Extension First Posted Date

Jun 5, 2012Estimated

Last Update Submitted Date

May 30, 2012

Last Update Posted Date

Jun 5, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to evaluate the safety and effectiveness of the investigational ketoprofen patch with a controlled heating patch, compared to placebo (inactive substance) for the treatment of pain caused by osteoarthritis.

Detailed Description

Proof-of-concept study, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of a transdermal ketoprofen patch with CHADD heat versus a placebo patch with dummy heat in patients with mild to moderate pain associated with osteoarthritis of the knee. After screening, patients discontinue all analgesic medication (except ≤325 mg aspirin daily for cardioprotective purposes). Patients selected a target knee (right or left), and all efficacy evaluations were completed with respect to this target knee. After discontinuing analgesics for at least 48 hours, and when the average pain intensity over the previous 24 hours for the target knee was ≥40 mm using a 100 mm visual analog scale (VAS), patients were randomized in a 1:1 fashion to receive treatment with either the transdermal ketoprofen patch with CHADD heat or the placebo patch with dummy heat. Patients treated the target knee each night for 12 hours (± 1 hour) for 4 weeks. Patients returned to the study site every 7 days (± 1 day) for study evaluations. Throughout the study, patients were allowed to take up to 2000 mg acetaminophen per day as rescue medication; however, rescue medication was not allowed within the 48 hours prior to efficacy evaluations.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

118Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transdermal Ketoprofen Patch with CHADD	Experimental		Drug: Transdermal Ketoprofen Patch with CHADD
Placebo patch and a dummy heating unit	Placebo Comparator		Drug: Placebo transdermal patch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transdermal Ketoprofen Patch with CHADD	Drug	12 hours patch application for 28 days	Transdermal Ketoprofen Patch with CHADD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in the WOMAC pain subscale score		28 days

Secondary Outcomes

Measure	Description	Time Frame
Number of participants wih adverse events		28 days
Patient Global Satisfaction score	Patient global satisfaction score at Study Visit 5	28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient is between forty (40) and seventy-five (75) years of age.
Patient has clinically diagnosed radiographic evidence of osteoarthritis of the knee within the past year.

Exclusion Criteria:

Patient has known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or other contraindication to any compound present in the study medication.
Patient has a history of significant gastrointestinal disease or previous gastrointestinal upset following NSAID administration.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Borenstein, MD	The Center for Rheumatology	Principal Investigator
H F Farmer, MD	Radiant Research Inc.	Principal Investigator
Larry Gilderman, DO	University Clinical Research	Principal Investigator
Soledad Lee, MD	Southbay Pharma Research	Principal Investigator
Joseph A Markenson, MD	Hospital for Special Surgery, New York	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SouthBay Pharma Research		Buena Park	California	90620	United States
The Center for Rheumatology and Bone Research

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D020370	Osteoarthritis, Knee
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001168	Arthritis

Browse Leaves

Not provided

Browse Branches

Not provided