SprainPhase 3NCT00765700
Ketoprofen 10% Cream for Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury
A Phase 3 study testing Topical Ketoprofen 10% Cream in people with Sprain and Strain, run by Imprimis Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
Imprimis Pharmaceuticals is investigating a proprietary, topical cream formulation consisting of 10% ketoprofen (containing 100 mg of ketoprofen in 1gram of cream) for the local treatment of acute musculoskeletal pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sprain, Strain, Acute Soft Tissue Injury
- What is being tested?
- Topical Ketoprofen 10% Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 364 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Sep 2009
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years of age
- Have a diagnosis of uncomplicated acute soft tissue injury of the upper or lower extremity that has occurred within the 72 hours preceding the baseline visit.
- The injury site must be accessible to the patient so that he or she can apply the study treatment himself or herself.
- Meet pain entry criteria.
- Willing to discontinue use of any pain medication or treatments not provided as part of the study.
Who cannot join
- 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 (e.g., nerve damage, joint instability, or tendon rupture).
- Previous injury to the same area within 3 months prior to current injury.
- Active skin lesions or disease at the intended site of application of the study medication. Skin lesions include open wounds, rash, papules, vesicles, and erythema associated with the site of injury.
- Pharmacologic treatment (NSAIDs or analgesic medications) for the injury less than 12 hours before the baseline assessments.
- Any form of opioid use since the time of injury.
- Any form of steroid use within 30 days prior to study entry.
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- Non-pharmacologic treatments of the injury other than rest, ice, compression, and/or elevation (RICE) prior to the baseline visit.
- History or physical examination finding that is not compatible with safe participation in the study as determined by the study doctor, such as gastrointestinal (stomach, intestine) ulcer or bleeding within 6 months documented by an upper-gastrointestinal series (UGI x-ray, barium meal) or endoscopy (GI scope), anemia or abnormal bleeding, moderate to severe kidney disease, or moderate to severe liver disease.
- A history of, or evidence for, underlying disease in the injured area, such as osteoarthritis or gout.
- Clinically significant, poorly controlled lung, stomach, liver, kidney, heart, or other vital organ disease as determined by the study doctor or nurse.
- A history of allergy to ketoprofen or ketoprofen-containing products.
- A history of allergy to soy lecithin or soy lecithin-containing products.
- Medications (drugs) or other substances contraindicated due to the nature of study medication that include:
- Allergies to prescription or over-the-counter products containing acetaminophen (e.g., Tylenol®), which is used as rescue medication
- History of aspirin-sensitive asthma, or aspirin-associated rhinitis or nasal polyps
- Taking warfarin, parenteral heparin, ticlopidine or clopidogrel
- Taking lithium or methotrexate
- Taking probenecid or similar drugs that might affect the kidneys
- Received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication.
- Scheduled elective surgery or other invasive procedures during the period of study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Assess the Efficacy and Safety of Ketotransdel™ (Ketoprofen Topical Cream 10%) in the Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury.
Imprimis Pharmaceuticals is investigating a proprietary, topical cream formulation consisting of 10% ketoprofen (containing 100 mg of ketoprofen in 1gram of cream) for the local treatment of acute musculoskeletal pain.
Read the detailed description
The primary objective of this study is to determine the efficacy and safety of ketoprofen 10% cream compared to placebo as a three-times-per-day topical application in improving the patient assessment of pain when used to treat mild to moderate acute soft tissue injury of the upper and lower extremities over a 7-day period.
- Conditions
- Sprain, Strain, Acute Soft Tissue Injury
- Being tested
- Topical Ketoprofen 10% Cream, Topical Placebo Cream
- Keywords
- Sprain, Strain, Pain, Ankle Pain, Shoulder Pain, Elbow Pain, Tennis Elbow, Knee pain, Wrist Pain, Hand Pain, Muscle, Bone and Cartilage Disorders
- Medical subject headings
- Sprains and Strains, Pain, Shoulder Pain, Tennis Elbow, Cartilage Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Ketoprofen 10% CreamDrug
Also called Ketotransdel (TDLP-110)
Topical Administration
Topical Placebo CreamDrug
Also called Placebo, Vehicle
Topical Administration
| Study group | Role | What they receive |
|---|---|---|
| Ketoprofen 10% Cream | Active comparator | Topical Ketoprofen 10% Cream
1gram three times daily for 7 days Receives: Drug: Topical Ketoprofen 10% Cream |
| Placebo | Placebo comparator | Topical placebo cream
1gram three times daily for 7 days Receives: Drug: Topical Placebo Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the efficacy of ketoprofen 10% cream in subjects with acute pain associated with mild to moderate acute soft tissue injury (acute sprain or strain) of upper and lower extremities on the day 3 visit.
Measured: 7 days
Secondary outcomes (1)
Assess the safety, tolerability and other parameters of ketoprofen 10% cream in subjects with acute pain associated with mild to moderate acute soft tissue injury of upper and lower extremities.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imprimis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cato Research
- Responsible party
- Sponsor
- Investigators
- Illana Katsnelson, MD, Study director, Cato Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765700
- Sponsor's protocol ID
- TDLP-110-101
- Status last verified
- Sep 2013
- First submitted
- 1 Oct 2008
- Last updated
- 27 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
E. Ekman, S. Skrepnik, M. Jones , K. Lawson, and J. Schupp. EFFICACY AND SAFETY OF KETOPROFEN 10% CREAM IN ACUTE SOFT TISSUE INJURIES (PHASE 3 STUDY TDLP-110-001). Poster Presentation, Sep. 2, 2010, 13th World Congress on Pain in Montreal, Canada.
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Assess the Efficacy and Safety of Ketotransdel™ (Ketoprofen Topical Cream 10%) in the Treatment of Pain Associated With Mild to Moderate Acute Soft Tissue Injury.
- ClinicalTrials.gov ID
- NCT00765700
- Acronym / sponsor ID
- TDLP-110-101
- Conditions
- Sprain, Strain, Acute Soft Tissue Injury
- Keywords
- Sprain, Strain, Pain, Ankle Pain, Shoulder Pain, Elbow Pain, Tennis Elbow, Knee pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Imprimis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cato Research
- Study start
- Sep 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 3 Oct 2008 (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.
Imprimis Pharmaceuticals is investigating a proprietary, topical cream formulation consisting of 10% ketoprofen (containing 100 mg of ketoprofen in 1gram of cream) for the local treatment of acute musculoskeletal pain.
Detailed description
The primary objective of this study is to determine the efficacy and safety of ketoprofen 10% cream compared to placebo as a three-times-per-day topical application in improving the patient assessment of pain when used to treat mild to moderate acute soft tissue injury of the upper and lower extremities over a 7-day period.
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 |
|---|---|---|
| Ketoprofen 10% Cream | Active comparator | Drug: Topical Ketoprofen 10% CreamTopical Ketoprofen 10% Cream 1gram three times daily for 7 days |
| Placebo | Placebo comparator | Drug: Topical Placebo CreamTopical placebo cream 1gram three times daily for 7 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 70 years of age
- Have a diagnosis of uncomplicated acute soft tissue injury of the upper or lower extremity that has occurred within the 72 hours preceding the baseline visit.
- The injury site must be accessible to the patient so that he or she can apply the study treatment himself or herself.
- Meet pain entry criteria.
- Willing to discontinue use of any pain medication or treatments not provided as part of the study.
Key exclusion criteria (20 listed)
- 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 (e.g., nerve damage, joint instability, or tendon rupture).
- Previous injury to the same area within 3 months prior to current injury.
- Active skin lesions or disease at the intended site of application of the study medication. Skin lesions include open wounds, rash, papules, vesicles, and erythema associated with the site of injury.
- Pharmacologic treatment (NSAIDs or analgesic medications) for the injury less than 12 hours before the baseline assessments.
- Any form of opioid use since the time of injury.
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 |
|---|---|---|
| Topical Ketoprofen 10% CreamAlso: Ketotransdel (TDLP-110)Topical Administration | Drug | Ketoprofen 10% Cream |
| Topical Placebo CreamAlso: Placebo, VehicleTopical Administration | Drug | Placebo |
Primary outcome
Assess the efficacy of ketoprofen 10% cream in subjects with acute pain associated with mild to moderate acute soft tissue injury (acute sprain or strain) of upper and lower extremities on the day 3 visit.
Time frame: 7 days
1 secondary outcome
Assess the safety, tolerability and other parameters of ketoprofen 10% cream in subjects with acute pain associated with mild to moderate acute soft tissue injury of upper and lower extremities.
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2013.
- Results publicationE. Ekman, S. Skrepnik, M. Jones , K. Lawson, and J. Schupp. EFFICACY AND SAFETY OF KETOPROFEN 10% CREAM IN ACUTE SOFT TISSUE INJURIES (PHASE 3 STUDY TDLP-110-001). Poster Presentation, Sep. 2, 2010, 13th World Congress on Pain in Montreal, Canada.
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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.
Illana Katsnelson, MD study director
Cato Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Topical Ketoprofen 10% Cream in people with Sprain and Strain, run by Imprimis Pharmaceuticals, Inc. at 1 site in United States.
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 20 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: finished, as of the sponsor's last update on 27 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess the efficacy of ketoprofen 10% cream in subjects with acute pain associated with mild to moderate acute soft tissue injury (acute sprain or strain) of upper and lower extremities on the day 3 visit. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00765700, which also lists 1 linked publication.
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 27 Sep 2013.