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

Imprimis Pharmaceuticals (Harrow Health)

Status and phase

Withdrawn

Phase 3

Conditions

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

Treatments

Drug: Ketoprofen 10% Cream

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01890902

IPI-110-002

Details and patient eligibility

About

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.

Sex

All

Ages

35+ years old

Volunteers

No 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.