Osteoarthritis of the KneePhase 2NCT01119898
Exploratory Study of PENNSAID Gel to Treat Symptoms of Knee Osteoarthritis
A Phase 2 study testing PENNSAID Gel in people with Osteoarthritis of the Knee, run by Mallinckrodt at 26 sites in United States.
Trial summary
Osteoarthritis (OA) is the most common form of arthritis. It can cause pain, swelling, and reduced motion in the joints. That can reduce quality of life. OA can occur in any joint, but usually affects the hands, knees, hips or spine. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- PENNSAID Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 26 sitesUnited States
- Study dates
- 2 Aug 2010to 16 Feb 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary osteoarthritis of the knee
- Radiologic evidence of OA of the knee
- On stable pain therapy with an oral or topical NSAID or acetaminophen
- Experience a "moderate flare" of pain following washout of stable pain therapy
- Able to read and understand English or Spanish to answer pain assessment questions without any explanation
- If female, surgically sterile or non-pregnant
- Except for OA, in reasonably good general health
- Written informed consent
Who cannot join
- Secondary OA of the study knee
- History of pseudo gout or inflammatory flare-ups
- Participation would conflict with contraindications, warnings or precautions as stated in the prescribing information for oral or topical diclofenac
- Severe, uncontrolled cardiac, renal, hepatic, or other systemic disease
- Any malignancy within the previous 3 years, except local therapy for superficial skin cancer not on the study knee
- Known sensitivity to the use of oral or topical diclofenac, aspirin [acetylsalicylic acid (ASA)] or any other NSAID, dimethyl sulfoxide (DMSO), or ethanol
Show all 30Show fewer
- Ongoing abnormality that could confound interpretation of the safety results (eg, anemia, unresponsive gastrointestinal [GI] reflux, etc.)
- Documented gastroduodenal ulcer or any GI bleeding (except hemorrhoidal) within the last 6 months
- Uncontrolled diabetes
- Screening laboratory test results of serum creatinine ≥ 1.5 times upper limit of normal; aspartate aminotransferase (AST), alanine aminotransferase (ALT), or gamma-glutamyltransferase (GGT) ≥ 3 times upper limit of normal; and hemoglobin less than or equal to lower limit of normal
- Documented alcohol or drug abuse within 1 year
- If female, breast-feeding
- Major surgery or previous damage to the study knee at any time, or minor knee surgery to the study knee within 1 year
- Requires oral or intra-muscular corticosteroids, or received an intra articular corticosteroid injection into the study knee within the past 90 days, or into any other joint within the past 30 days, or currently applying topical corticosteroids onto the study knee
- Received intra-articular viscosupplementation (eg, hylan G-F 20 [Synvisc®]) in the study knee in the past 6 months
- On prior stable therapy (ie, more than 3 days per week for the previous month) with an opioid analgesic prior to the screening visit will be excluded.
- Recently started taking a sedative hypnotic medication for insomnia
- Taking anti-depressants
- Not willing to discontinue prohibited medications/therapies
- Cannot tolerate acetaminophen
- Re-entering study after dropping out or withdrawn from study
- Used another investigational drug within the previous 30 days
- On or currently applying for disability benefits on the basis of knee OA
- History of fibromyalgia
- Other painful or disabling conditions affecting the knee or leg, or disabling condition of the hands (used to apply the study drug)
- Skin disorder with current involvement on the hands (used to apply the study drug) or the knee(s) (application site)
- Referred to an orthopedic surgeon for consideration of, or been advised to have, knee replacement or knee reconstruction surgery
- Radiologic evidence of OA of the knee advanced to the point that all cartilage has been eroded (ie, bone on bone)
- Recently started using a cane within the past 30 days
- History of chronic headaches that may require more than occasional use of rescue medication for headaches
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Radiant Research Inc.
Anderson, South Carolina, 29261
Clinical Study Center of Asheville
Asheville, North Carolina, 28803
Charlottesville Medical Research
Charlottesville, Virginia, 22911
Sterling Research
Cincinnati, Ohio, 45246
Tampa Bay Medical Research, Inc
Clearwater, Florida, 33761
Radiant Research Inc.
Columbus, Ohio, 43212
Avail Clinical Research
DeLand, Florida, 32724
Sterling Research
Erlanger, Kentucky, 41018
Benchmark Research
Fort Worth, Texas, 76135
Peters Medical Research, LLC
High Point, North Carolina, 27262
Holston Medical Group Clinical Research
Kingsport, Tennessee, 37660
Drug Studies America
Marietta, Georgia, 30060
Palmetto Medical Research
Mt. Pleasant, South Carolina, 29464
Clinical Research Source, Inc.
Perrysburg, Ohio, 43551
Clinical Trials Technology, Inc.
Prairie Village, Kansas, 66206
HypotheTest, LLC
Roanoke, Virginia, 24018
Benchmark Research
Sacramento, California, 95816
Crescent Medical Research
Salisbury, North Carolina, 28144
Benchmark Research
San Angelo, Texas, 76904
Sun Research Institute
San Antonio, Texas, 78215
South Coast Medical Group
Savannah, Georgia, 31406
Radiant Research Inc.
St Louis, Missouri, 63141
Sundance Clinical Research
St Louis, Missouri, 63141
Comprehensive NeuroScience Inc.
St. Petersburg, Florida, 33716
Genova Clinical Research
Tucson, Arizona, 85741
New Hanover Medical Research
Wilmington, North Carolina, 28401
About this study
Official title: A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Clinical Study to Evaluate the Safety and Efficacy of PENNSAID Gel in the Symptomatic Treatment of Osteoarthritis of the Knee
Osteoarthritis (OA) is the most common form of arthritis. It can cause pain, swelling, and reduced motion in the joints. That can reduce quality of life.
OA can occur in any joint, but usually affects the hands, knees, hips or spine.
The purpose of this study is to find out if doctors might be able to use 2% PENNSAID gel to treat OA in the knee.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- PENNSAID Gel, Vehicle
- Keywords
- Osteoarthritis, Arthritis, NSAIDs, Topical NSAID, Diclofenac, PENNSAID
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENNSAID GelDrug
Also called diclofenac sodium 2.0% w/w
2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
VehicleDrug
2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| PENNSAID Gel | Experimental | Diclofenac sodium 2.0% w/w Receives: Drug: PENNSAID Gel |
| Vehicle | Placebo comparator | The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain When Walking On A Flat Surface
Participants rate their pain intensity when walking on a flat surface as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Measured: at Baseline
Pain When Walking On A Flat Surface
Participants rate their pain intensity when walking on a flat surface as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Measured: at Week 4
Pain When Going Up Or Down Stairs
Participants rate their pain intensity when going up or down stairs as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Measured: at Baseline
Pain When Going Up Or Down Stairs
Participants rate their pain intensity when going up or down stairs as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Measured: at Week 4
Pain At Night While In Bed
Participants rate their pain intensity at night while in bed as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Measured: at Baseline
Pain At Night While In Bed
Participants rate their pain intensity at night while in bed as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Measured: at Week 4
Pain While Sitting Or Lying Down
Participants rate their pain intensity while sitting or lying down as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Measured: at Baseline
Pain While Sitting Or Lying Down
Participants rate their pain intensity while sitting or lying down as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Measured: at Week 4
Pain While Standing
Participants rate their pain intensity while standing as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Measured: at Baseline
Pain While Standing
Participants rate their pain intensity while standing as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Measured: at Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2010 (estimated)
- Study start2 Aug 2010
- Primary completion16 Feb 2011
- Study completion16 Feb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Pierro, MD, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119898
- Sponsor's protocol ID
- COV05100031
- Status last verified
- Oct 2019
- First submitted
- 28 Apr 2010
- Last updated
- 22 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wadsworth LT, Kent JD, Holt RJ. Efficacy and safety of diclofenac sodium 2% topical solution for osteoarthritis of the knee: a randomized, double-blind, vehicle-controlled, 4 week study. Curr Med Res Opin. 2016;32(2):241-50. doi: 10.1185/03007995.2015.1113400. Epub 2015 Nov 17.
PubMed 26506138
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Clinical Study to Evaluate the Safety and Efficacy of PENNSAID Gel in the Symptomatic Treatment of Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT01119898
- Acronym / sponsor ID
- COV05100031
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Osteoarthritis, Arthritis, NSAIDs, Topical NSAID, Diclofenac, PENNSAID
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2010 (actual)
- Primary completion
- 16 Feb 2011 (actual)
- Study completion
- 16 Feb 2011 (actual)
- First posted
- 10 May 2010 (estimated)
- Results
- Posted 22 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoarthritis (OA) is the most common form of arthritis. It can cause pain, swelling, and reduced motion in the joints. That can reduce quality of life.
OA can occur in any joint, but usually affects the hands, knees, hips or spine.
The purpose of this study is to find out if doctors might be able to use 2% PENNSAID gel to treat OA in the knee.
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 |
|---|---|---|
| PENNSAID Gel | Experimental | Drug: PENNSAID GelDiclofenac sodium 2.0% w/w |
| Vehicle | Placebo comparator | Drug: VehicleThe complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Primary osteoarthritis of the knee
- Radiologic evidence of OA of the knee
- On stable pain therapy with an oral or topical NSAID or acetaminophen
- Experience a "moderate flare" of pain following washout of stable pain therapy
- Able to read and understand English or Spanish to answer pain assessment questions without any explanation
Key exclusion criteria (30 listed)
- Secondary OA of the study knee
- History of pseudo gout or inflammatory flare-ups
- Participation would conflict with contraindications, warnings or precautions as stated in the prescribing information for oral or topical diclofenac
- Severe, uncontrolled cardiac, renal, hepatic, or other systemic disease
- Any malignancy within the previous 3 years, except local therapy for superficial skin cancer not on the study knee
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 |
|---|---|---|
| PENNSAID GelAlso: diclofenac sodium 2.0% w/w2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks | Drug | PENNSAID Gel |
| Vehicle2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks | Drug | Vehicle |
Primary outcome
Pain When Walking On A Flat Surface
Time frame: at Baseline
Participants rate their pain intensity when walking on a flat surface as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Pain When Walking On A Flat Surface
Time frame: at Week 4
Participants rate their pain intensity when walking on a flat surface as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Pain When Going Up Or Down Stairs
Time frame: at Baseline
Participants rate their pain intensity when going up or down stairs as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Pain When Going Up Or Down Stairs
Time frame: at Week 4
Participants rate their pain intensity when going up or down stairs as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Pain At Night While In Bed
Time frame: at Baseline
Participants rate their pain intensity at night while in bed as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Pain At Night While In Bed
Time frame: at Week 4
Participants rate their pain intensity at night while in bed as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Pain While Sitting Or Lying Down
Time frame: at Baseline
Participants rate their pain intensity while sitting or lying down as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Pain While Sitting Or Lying Down
Time frame: at Week 4
Participants rate their pain intensity while sitting or lying down as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Pain While Standing
Time frame: at Baseline
Participants rate their pain intensity while standing as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Pain While Standing
Time frame: at Week 4
Participants rate their pain intensity while standing as none, mild, moderate, severe or extreme. The number of participants who rate their pain in each category is presented.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26506138Wadsworth LT, Kent JD, Holt RJ. Efficacy and safety of diclofenac sodium 2% topical solution for osteoarthritis of the knee: a randomized, double-blind, vehicle-controlled, 4 week study. Curr Med Res Opin. 2016;32(2):241-50. doi: 10.1185/03007995.2015.1113400. Epub 2015 Nov 17.
- Individual participant dataSharing planned: No
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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.
Joseph Pierro, MD study director
Mallinckrodt
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PENNSAID Gel in people with Osteoarthritis of the Knee, run by Mallinckrodt at 26 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 8 inclusion and 30 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 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 When Walking On A Flat Surface (time frame: at Baseline). The study lists 10 primary outcomes in all. 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 NCT01119898, 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 22 Oct 2019.