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

A Randomized, Multicenter, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Impracor (Ketoprofen 10% Cream) Compared With Placebo in the Treatment of Acute Pain (Flare) Associated With Osteoarthritis of the Knee

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01890902

Enrollment

Registered

2013-07-02

Start date

2013-08-31

Completion date

Unknown

Last updated

2013-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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.

Interventions

DRUGKetoprofen 10% Cream

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

35 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The primary endpoint will be measured by changes in WOMAC pain subscale scores calculated by comparing baseline WOMAC pain subscale scores on Day 1 to the average WOMAC Pain Subscale scores on Day 4, 6, and 8.	Day 4, 6 and 8

Secondary

Measure	Time frame
Change in Patient Global Assessment of knee arthritis using the modified Patient Overall Health Assessment from Day 1 to Day 8.	Day 8

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026