Osteoarthritis of the KneePhase 3NCT00722852
Study of Safety and Efficacy of Diractin® for the Treatment of Osteoarthritis (OA) of the Knee
A Phase 3 study testing ketoprofen in Diractin® in people with Osteoarthritis of the Knee, run by IDEA AG at 37 sites in United States.
Trial summary
The purpose of this study is to provide replicated evidence of safety and efficacy of 100 mg ketoprofen in Diractin®. Read more about this study
- Who is it for?
- Ages 46 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- ketoprofen in Diractin®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 555 participants
- Where
- 37 sitesUnited States
- Study dates
- Jun 2008to Apr 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 46 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent signed and dated
- Age > 45 years
- Class I-III OA of the knee and subject meets American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of the knee
Who cannot join
- Skin lesions or dermatological diseases in the treatment area
- Directly or indirectly involved in the conduct and administration of this study
- Received any investigational medicinal product within 30 days prior to Screening Visit or participation in any previous clinical study with Diractin®
- Pregnancy or lactation
- Residents of psychiatric wards, prisons or other state institutions
- Malignancy within the past 2 years
Show all 13Show fewer
- Depressive disorders requiring treatment with tricyclics, treatment with other antidepressants must be stable for 3 months prior to screening and throughout the study
- Epilepsy
- Schizophrenia
- Neuropathic pain and any other pain condition requiring chronic use of pain medication
- Known hypersensitivity or allergy (including photoallergy) to NSAID´s including ketoprofen and to ingredients of the IMP
- Preexisting asthma or bronchospasm after taking aspirin or other NSAIDs
- Unable to discontinue analgesic therapy including opioids, NSAID´s, tramadol, muscle relaxants, gabapentin, pregabalin, duloxetine, venlafaxine, capsaicine or other drugs approved or used for the treatment of pain for the duration of the study
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Orange County Clinical Trails, Inc.
Anaheim, California, 92801
Advance Clinical Research Insititute
Boise, Idaho, 83704
Tampa Bay Medical Research Inc.
Clearwater, Florida, 33761
Rapid Medical Research, Inc.
Cleveland, Ohio, 44122
University Clinical Research DeLand, LCC
DeLand, Florida, 32720
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714
Coastal Carolina Research Center
Goose Creek, South Carolina, 29445
Eastern Research
Hialeah, Florida, 33458
Sarah Cannon Research Institute
Jackson, Tennessee, 38305
DSI
Jupiter, Florida, 33458
Westside Family Medical Center, P.C.
Kalamazoo, Michigan, 49009
FPA Clinical Research
Kissimmee, Florida, 34741
Family Practice Lynn Institute of the Ozarks
Little Rock, Arkansas, 72205
Drug Studies America
Marietta, Georgia, 30060
Non-Surgical Orthopaedic & Spine Center, P.C.
Marietta, Georgia, 30060
Lousianna Research Associates Inc. (LRC, Inc)
New Orleans, Louisiana, 70114
Suncoast Clinical Research Family Practice
New Port Richey, Florida, 34652
Renstar Medical Research
Ocala, Florida, 34471
Omaha Research, P.C.
Omaha, Nebraska, 68116
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024
Founders Research Group Research
Philadelphia, Pennsylvania, 19152
Hope Research Institute
Phoenix, Arizona, 85016
Wake Research Associates, LLC
Raleigh, North Carolina, 27612
Rochester Clinical Research
Rochester, New York, 14609
Quality Research Inc.
San Antonio, Texas, 78209
Progressive Clinical Research
San Antonio, Texas, 78229
Miami Research Associates
South Miami, Florida, 33143
Encompass Clinical Research
Spring Valley, California, 91978
Future Care Studies
Springfield, Massachusetts, 01107
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Premiere Pharmaceutical Research
Tempe, Arizona, 85282
Genova Clinical Research
Tucson, Arizona, 85741
Omega Medical Research
Warwick, Rhode Island, 02886
Integrated Clinical Trail Services, Inc.
West Des Moines, Iowa, 50265
The Center of Clinical Research LLC
Winston-Salem, North Carolina, 27103
Pharcotherapy Research Associate, Inc.
Zanesville, Ohio, 43701
About this study
Official title: Multicentre, Randomized, Double-blind, Placebo-controlled Study of Safety and Efficacy of Epicutaneously Applied Diractin® (Ketoprofen in Transfersome® Gel) for the Treatment of Osteoarthritis of the Knee
The purpose of this study is to provide replicated evidence of safety and efficacy of 100 mg ketoprofen in Diractin®.
Read the detailed description
The study will investigate safety and efficacy of Diractin® at relieving signs and symptoms of knee OA, including the primary endpoint of patient assessment of pain.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- ketoprofen in Diractin®, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketoprofen in Diractin®Drug
100 mg (b.i.d.)
PlaceboDrug
100 mg (b.i.d.)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ketoprofen in Diractin® |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain subscale of the WOMAC
Measured: week 12
Secondary outcomes (2)
Patient global assessment of response to therapy
Measured: week 12
function subscale of the WOMAC
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionFeb 2009
- Study completionApr 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 Osteoarthritis of the KneeStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 555 participants (actual)
Sponsor and investigators
- Lead sponsor
- IDEA AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- IDEA AG, Study director, IDEA AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722852
- Sponsor's protocol ID
- CL-033-III-06
- Status last verified
- Oct 2009
- First submitted
- 24 Jul 2008
- Last updated
- 5 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Rother M, Conaghan PG. A randomized, double-blind, phase III trial in moderate osteoarthritis knee pain comparing topical ketoprofen gel with ketoprofen-free gel. J Rheumatol. 2013 Oct;40(10):1742-8. doi: 10.3899/jrheum.130192. Epub 2013 Sep 1.
PubMed 23996292
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Randomized, Double-blind, Placebo-controlled Study of Safety and Efficacy of Epicutaneously Applied Diractin® (Ketoprofen in Transfersome® Gel) for the Treatment of Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00722852
- Acronym / sponsor ID
- CL-033-III-06
- Conditions
- Osteoarthritis of the Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 555 participants (actual)
- Lead sponsor
- IDEA AGIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 28 Jul 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.
The purpose of this study is to provide replicated evidence of safety and efficacy of 100 mg ketoprofen in Diractin®.
Detailed description
The study will investigate safety and efficacy of Diractin® at relieving signs and symptoms of knee OA, including the primary endpoint of patient assessment of pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ketoprofen in Diractin® |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 46 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent signed and dated
- Age > 45 years
- Class I-III OA of the knee and subject meets American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of the knee
Key exclusion criteria (13 listed)
- Skin lesions or dermatological diseases in the treatment area
- Directly or indirectly involved in the conduct and administration of this study
- Received any investigational medicinal product within 30 days prior to Screening Visit or participation in any previous clinical study with Diractin®
- Pregnancy or lactation
- Residents of psychiatric wards, prisons or other state institutions
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 in Diractin®100 mg (b.i.d.) | Drug | 1 |
| Placebo100 mg (b.i.d.) | Drug | 2 |
Primary outcome
pain subscale of the WOMAC
Time frame: week 12
2 secondary outcomes
Patient global assessment of response to therapy
Time frame: week 12
function subscale of the WOMAC
Time frame: week 12
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 5 Oct 2009.
- Derived from this study: PubMed 23996292Rother M, Conaghan PG. A randomized, double-blind, phase III trial in moderate osteoarthritis knee pain comparing topical ketoprofen gel with ketoprofen-free gel. J Rheumatol. 2013 Oct;40(10):1742-8. doi: 10.3899/jrheum.130192. Epub 2013 Sep 1.
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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.
IDEA AG study director
IDEA AG
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ketoprofen in Diractin® in people with Osteoarthritis of the Knee, run by IDEA AG at 37 sites 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 3 inclusion and 13 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 5 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites 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?
pain subscale of the WOMAC (time frame: week 12). 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 NCT00722852, 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 5 Oct 2009.