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

NCT01890902 | Withdrawn Phase 3

• 1 other identifier: IPI-110-002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Day 8

Study Arms (2)

Impracor (Ketoprofen 10% Cream)

EXPERIMENTAL

Topical Cream over a period of 14 days

Drug: Ketoprofen 10% Cream

Placebo Cream:

PLACEBO COMPARATOR

Topical Cream over a period of 14 days

Drug: Placebo

Interventions

Ketoprofen 10% Cream DRUG

Also known as: Impracor, IPI-110

Impracor (Ketoprofen 10% Cream)

Placebo DRUG

Placebo Cream:

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imprimis Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Acute Pain

Interventions

Ketoprofen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 2, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2014
• Last Updated: November 13, 2013

Record last verified: 2013-11