search
Back to results

Ketoprofen 10% Cream for Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury

Primary Purpose

Sprain

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Withdrawn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 Sprain focused on measuring Sprain, Strain, Pain, Ankle Pain, Knee Pain, Wrist Pain, Hand Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Are male or female and 18 to 75 years of age, inclusive.
  • Female patients of childbearing potential must practice abstinence or be using a medically acceptable form of contraception
  • Have a diagnosis of uncomplicated acute soft tissue injury of the upper or lower extremity, including acute injuries of ligaments, tendons, or muscles (including Grade 1 or Grade 2 sprain or strain), that has occurred within the 60 hours preceding the baseline visit.
  • Meet pain intensity criteria
  • Are willing to discontinue use of any pain medication or treatments not provided as part of the study.

Exclusion Criteria:

  • Participation in a previous clinical study with the drug TDLP-110 (ketoprofen 10% cream).
  • Are pregnant or lactating.
  • Have a Grade 3 sprain or strain, bilateral sprain or strain, or concomitant fracture or open wound at the site of the sprain or strain, or have a serious injury, as determined by the investigator
  • Have a shoulder (rotator cuff) injury.
  • Have been treated for a sprain or strain of the same site within the past 3 months.
  • Have contusions at the site of acute soft tissue injury intended for treatment.
  • Have active skin lesions or disease at the intended site of application of the study medication.
  • Have had pharmacologic treatment for the injury less than 24 hours before the baseline assessments
  • Use of any oral or parenteral corticosteroids within 30 days of injury.
  • Have had non-pharmacologic treatments of the injury other than rest, ice, compression, and/or elevation (RICE) within 12 hours prior to the baseline visit.
  • Have a history or physical examination finding that is incompatible with safe participation in the study.
  • Have a history or physical examination finding that is, in the opinion of the investigator, incompatible with study product use or with obtaining interpretable data.
  • Are taking medications or other substances contraindicated due to the nature of the study medication or with the potential for drug interactions.
  • Are allergic or sensitive to soy lecithin or soy lecithin-containing products.
  • Are taking probenecid or similar drugs that may significantly affect renal function.
  • Are taking a sleep medication, sedative hypnotic, anxiolytic, or antidepressant medication at a dose that has not been stable for at least 2 months.
  • Are receiving physical therapy for the index injury
  • Have scheduled elective surgery or other invasive procedures during the period of study participation.
  • Have any illness or concurrent condition that would, in the opinion of the investigator, make study participation unsafe or would confound study results ly undergoing treatment for chronic pain, or severe systemic disease).
  • Have received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication.
  • Have an active worker's compensation claim or personal injury claim regarding injury to the index site.
  • Are suspected by the investigator of recent or current drug or alcohol abuse.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Active

    Placebo Cream

    Arm Description

    Topical ketoprofen 10% Cream

    Placebo Cream

    Outcomes

    Primary Outcome Measures

    Change from baseline in mean pain intensity (100 mm VAS) during daily activities over the past 24 hours at the Day 3 visit (Day 3 +1)

    Secondary Outcome Measures

    CPRA; Pain curves over time; Percent change from baseline
    Cumulative proportion of responders for the change from baseline in mean pain intensity as assessed on the 100-mm VAS during daily activities over the past 24 hours at Day 3. Change from baseline in three-times-daily pain intensity using VAS ratings recorded in the patient diaries over 7 days of treatment. Percent change from baseline in pain intensity during daily activities over the past 24 hours at Day 3

    Full Information

    First Posted
    October 8, 2010
    Last Updated
    September 4, 2012
    Sponsor
    Imprimis Pharmaceuticals, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01223053
    Brief Title
    Ketoprofen 10% Cream for Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury
    Official Title
    A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Confirmatory Phase 3 Study to Assess the Efficacy and Safety of TDLP-110 (Ketotransdel®, Ketoprofen 10% Cream) in the Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2012
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Revised Development Program
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Imprimis Pharmaceuticals, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    Transdel Pharmaceuticals is investigating a topical cream formulation consisting of 10% ketoprofen for the local treatment of pain associated with mild to moderate acute soft tissue injury in this confirmatory Phase 3 trial.
    Detailed Description
    This Phase 3 study examines the use of TDLP-110 (a.k.a. Ketotransdel® or ketoprofen 10% cream), as a topical treatment for pain associated with mild to moderate acute soft tissue injury of the upper and lower extremities to serve as a confirmatory trial. The first completed Phase 3 study showed efficacy and safety of TDLP-110 compared to placebo in improving the patient assessment of pain.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sprain
    Keywords
    Sprain, Strain, Pain, Ankle Pain, Knee Pain, Wrist Pain, Hand Pain

    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
    Active
    Arm Type
    Active Comparator
    Arm Description
    Topical ketoprofen 10% Cream
    Arm Title
    Placebo Cream
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo Cream
    Intervention Type
    Drug
    Intervention Name(s)
    Ketoprofen 10% cream
    Other Intervention Name(s)
    TDLP-110, Ketotransdel
    Intervention Description
    100 mg (10%) in 1 gram of topical cream applied three times per day for 7 days. Safety follow up on day 14.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Matching placebo cream containing identical constituents as the active comparator except for ketoprofen
    Primary Outcome Measure Information:
    Title
    Change from baseline in mean pain intensity (100 mm VAS) during daily activities over the past 24 hours at the Day 3 visit (Day 3 +1)
    Time Frame
    3 days
    Secondary Outcome Measure Information:
    Title
    CPRA; Pain curves over time; Percent change from baseline
    Description
    Cumulative proportion of responders for the change from baseline in mean pain intensity as assessed on the 100-mm VAS during daily activities over the past 24 hours at Day 3. Change from baseline in three-times-daily pain intensity using VAS ratings recorded in the patient diaries over 7 days of treatment. Percent change from baseline in pain intensity during daily activities over the past 24 hours at Day 3
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Are male or female and 18 to 75 years of age, inclusive. Female patients of childbearing potential must practice abstinence or be using a medically acceptable form of contraception Have a diagnosis of uncomplicated acute soft tissue injury of the upper or lower extremity, including acute injuries of ligaments, tendons, or muscles (including Grade 1 or Grade 2 sprain or strain), that has occurred within the 60 hours preceding the baseline visit. Meet pain intensity criteria Are willing to discontinue use of any pain medication or treatments not provided as part of the study. Exclusion Criteria: Participation in a previous clinical study with the drug TDLP-110 (ketoprofen 10% cream). Are pregnant or lactating. Have a Grade 3 sprain or strain, bilateral sprain or strain, or concomitant fracture or open wound at the site of the sprain or strain, or have a serious injury, as determined by the investigator Have a shoulder (rotator cuff) injury. Have been treated for a sprain or strain of the same site within the past 3 months. Have contusions at the site of acute soft tissue injury intended for treatment. Have active skin lesions or disease at the intended site of application of the study medication. Have had pharmacologic treatment for the injury less than 24 hours before the baseline assessments Use of any oral or parenteral corticosteroids within 30 days of injury. Have had non-pharmacologic treatments of the injury other than rest, ice, compression, and/or elevation (RICE) within 12 hours prior to the baseline visit. Have a history or physical examination finding that is incompatible with safe participation in the study. Have a history or physical examination finding that is, in the opinion of the investigator, incompatible with study product use or with obtaining interpretable data. Are taking medications or other substances contraindicated due to the nature of the study medication or with the potential for drug interactions. Are allergic or sensitive to soy lecithin or soy lecithin-containing products. Are taking probenecid or similar drugs that may significantly affect renal function. Are taking a sleep medication, sedative hypnotic, anxiolytic, or antidepressant medication at a dose that has not been stable for at least 2 months. Are receiving physical therapy for the index injury Have scheduled elective surgery or other invasive procedures during the period of study participation. Have any illness or concurrent condition that would, in the opinion of the investigator, make study participation unsafe or would confound study results ly undergoing treatment for chronic pain, or severe systemic disease). Have received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication. Have an active worker's compensation claim or personal injury claim regarding injury to the index site. Are suspected by the investigator of recent or current drug or alcohol abuse.

    12. IPD Sharing Statement

    Learn more about this trial

    Ketoprofen 10% Cream for Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury

    We'll reach out to this number within 24 hrs