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Withdrawn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
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
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
NCT ID
NCT01223053
First Posted
October 8, 2010
Last Updated
September 4, 2012
Sponsor
Imprimis Pharmaceuticals, Inc.
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
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