SprainPhase 3NCT01223053
Ketoprofen 10% Cream for Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury
A Phase 3 study testing Ketoprofen 10% cream in people with Sprain, run by Imprimis Pharmaceuticals, Inc..
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sprain
- What is being tested?
- Ketoprofen 10% cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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
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.
Read the 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.
- Conditions
- Sprain
- Being tested
- Ketoprofen 10% cream, Placebo
- Keywords
- Sprain, Strain, Pain, Ankle Pain, Knee Pain, Wrist Pain, Hand Pain
- Medical subject headings
- Sprains and Strains, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketoprofen 10% creamDrug
Also called TDLP-110, Ketotransdel
100 mg (10%) in 1 gram of topical cream applied three times per day for 7 days. Safety follow up on day 14.
PlaceboDrug
Matching placebo cream containing identical constituents as the active comparator except for ketoprofen
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Topical ketoprofen 10% Cream Receives: Drug: Ketoprofen 10% cream |
| Placebo Cream | Placebo comparator | Placebo Cream Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 days
Secondary outcomes (1)
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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
Why it stopped: Revised Development Program
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SprainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imprimis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223053
- Sponsor's protocol ID
- TDLP-110-002
- Status last verified
- Sep 2012
- First submitted
- 8 Oct 2010
- Last updated
- 5 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01223053
- Acronym / sponsor ID
- TDLP-110-002
- Conditions
- Sprain
- Keywords
- Sprain, Strain, Pain, Ankle Pain, Knee Pain, Wrist Pain, Hand Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Revised Development Program
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imprimis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- First posted
- 18 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: Ketoprofen 10% creamTopical ketoprofen 10% Cream |
| Placebo Cream | Placebo comparator | Drug: PlaceboPlacebo Cream |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketoprofen 10% creamAlso: TDLP-110, Ketotransdel100 mg (10%) in 1 gram of topical cream applied three times per day for 7 days. Safety follow up on day 14. | Drug | Active |
| PlaceboMatching placebo cream containing identical constituents as the active comparator except for ketoprofen | Drug | Placebo Cream |
Primary outcome
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
1 secondary outcome
CPRA; Pain curves over time; Percent change from baseline
Time frame: 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketoprofen 10% cream in people with Sprain, run by Imprimis Pharmaceuticals, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2012.