Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01223053
Other study ID # TDLP-110-002
Secondary ID
Status Withdrawn
Phase Phase 3
First received October 8, 2010
Last updated September 4, 2012

Study information

Verified date September 2012
Source Imprimis Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Description:

This Phase 3 study examines the use of TDLP-110 (a.k.a. KetotransdelĀ® 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ketoprofen 10% cream
100 mg (10%) in 1 gram of topical cream applied three times per day for 7 days. Safety follow up on day 14.
Placebo
Matching placebo cream containing identical constituents as the active comparator except for ketoprofen

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Imprimis Pharmaceuticals, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 3 days No
Secondary 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
7 days No
See also
  Status Clinical Trial Phase
Completed NCT00765700 - Ketoprofen 10% Cream for Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury Phase 3
Recruiting NCT02285868 - ATI Evidence-based Guide Investigating Clinical Services
Withdrawn NCT00954785 - Etoricoxib in Acute Ankle Ligament Sprains Phase 4
Completed NCT02916940 - Injection of Corticoids for the Treatment of Acute Sprains of the Proximal Interphalangeal Joints of the Fingers. Phase 2
Terminated NCT01508728 - Efficacy Study of a Sensory Feedback Knee Orthosis in Patients Suffering From Unoperated Severe Knee Sprain Phase 2
Completed NCT00351104 - Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Ankle Sprain or Strain Phase 3
Completed NCT00671320 - A Multi-Center, Randomized, Double-Blind, Parallel Group Study To Compare The Efficacy And Tolerability Of Valdecoxib And Diclofenac In Patients With A Sprained Ankle Phase 4
Not yet recruiting NCT02346786 - Epidemiology of Incidents and Accidents in Sport. Influence of Moisture. Phase 3
Completed NCT00601471 - Effects of Proximal and Distal Tibiofibular Joint Manipulation on Lower Extremity Muscle Activation, Ankle Range of Motion, and Functional Outcome Scores in Individuals With Chronic Ankle Instability N/A