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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

Primary Purpose

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

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ketoprofen 10% Cream
Placebo
Sponsored by
Imprimis Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain (Flare) Associated With Osteoarthritis (OA) of the Knee

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Impracor (Ketoprofen 10% Cream)

    Placebo Cream:

    Arm Description

    Topical Cream over a period of 14 days

    Topical Cream over a period of 14 days

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    June 27, 2013
    Last Updated
    November 8, 2013
    Sponsor
    Imprimis Pharmaceuticals, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01890902
    Brief Title
    Efficacy and Safety of Impracor (Ketoprofen 10% Cream) Compared With Placebo in the Treatment of Acute Pain (Flare) Associated With Osteoarthritis of the Knee
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2013
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    August 2013 (undefined)
    Primary Completion Date
    June 2014 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Imprimis Pharmaceuticals, Inc.

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Pain (Flare) Associated With Osteoarthritis (OA) of the Knee

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Impracor (Ketoprofen 10% Cream)
    Arm Type
    Experimental
    Arm Description
    Topical Cream over a period of 14 days
    Arm Title
    Placebo Cream:
    Arm Type
    Placebo Comparator
    Arm Description
    Topical Cream over a period of 14 days
    Intervention Type
    Drug
    Intervention Name(s)
    Ketoprofen 10% Cream
    Other Intervention Name(s)
    Impracor, IPI-110
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    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.
    Time Frame
    Day 4, 6 and 8
    Secondary Outcome Measure Information:
    Title
    Change in Patient Global Assessment of knee arthritis using the modified Patient Overall Health Assessment from Day 1 to Day 8.
    Time Frame
    Day 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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