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Efficacy and Safety of Impracor (Ketoprofen 10% Cream) Compared With Placebo in the Treatment of Acute Pain (Flare) Associated With Osteoarthritis of the Knee

NCT ID: NCT01890902

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Brief Summary

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The primary objective of the study is to assess analgesic efficacy of Impracor (Ketoprofen 10% Cream) compared to placebo for acute pain associated with OA flare of the knee.

Detailed Description

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Conditions

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Acute Pain (Flare) Associated With Osteoarthritis (OA) of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Impracor (Ketoprofen 10% Cream)

Topical Cream over a period of 14 days

Group Type EXPERIMENTAL

Ketoprofen 10% Cream

Intervention Type DRUG

Placebo Cream:

Topical Cream over a period of 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Ketoprofen 10% Cream

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Impracor IPI-110

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of OA of the knee according to the ACR criteria.
* Kellgren-Lawrence grade 2-3 disease
* Be willing to stop taking all analgesics including NSAIDs and opioids for the duration of the study, with exception of study-specified rescue medication.

Exclusion Criteria

* Total knee replacement surgery tentatively scheduled within next 6 months.
* Palpable knee effusion.
* Significant pain outside the target knee, including significant hip, back, or contralateral knee pain.
* Any type of orthopedic and/or prosthetic device or any skin abnormalities on the target knee that would prevent evaluations of local tolerability.
* History of asthma, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis), or fibromyalgia.
* History of gastrointestinal bleeding or peptic ulcer disease within the past 3 years.
* Have a positive urine drug test for illegal drug substances, non-prescribed controlled substances, or alcohol at screening.
* Acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the subject at risk by participating in the study.
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imprimis Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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IPI-110-002

Identifier Type: -

Identifier Source: org_study_id