CompletedNCT01119898Updated Oct 22, 2019Results posted

Exploratory Study of PENNSAID Gel to Treat Symptoms of Knee Osteoarthritis

A Phase 2 interventional study of PENNSAID Gel and Vehicle in Osteoarthritis of the Knee, sponsored by Mallinckrodt. Completed at 26 sites in United States. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-10-22.

Sponsored by Mallinckrodt · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 260
Allocation: Randomized
Ages: 40 Years to 85 Years
Sex: All

Study 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.

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 studied

Osteoarthritis of the Knee

Browse trials for

Keywords

Osteoarthritis
Arthritis
NSAIDs
Topical NSAID
Diclofenac
PENNSAID

In context

Osteoarthritis, Knee

3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.

This study's enrollment of 260 is above the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Mallinckrodt is the lead sponsor of 87 studies on the registry; none are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 15 (100%) have results posted.

Browse Keenova Therapeutics plc studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 40 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 260 participants (actual)

Study arms

Experimental
PENNSAID Gel
Diclofenac sodium 2.0% w/w
Drug: PENNSAID Gel
Placebo comparator
Vehicle
The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium
Drug: Vehicle

Interventions

DrugPENNSAID Gel
2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
Also known as: diclofenac sodium 2.0% w/w
DrugVehicle
2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at Week 4

Results

Posted Oct 22, 2019

Participant flow

Participant flow — Overall Study
Milestone	PENNSAID Gel	Vehicle
Started	131	129
Received study drug (mitt)	130	129
Completed	123	117
Not completed	8	12
Withdrew: Adverse event	4	5
Withdrew: Withdrawal by subject	1	4
Withdrew: Lack of efficacy	0	2
Withdrew: Protocol violation	1	1
Withdrew: Medical procedure	1	0
Withdrew: Randomized in error did not participate	1	0

Outcome measures

PrimaryPain 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.

Time frame:: at Baseline
Reported as:: Count of participants · Participants

Pain When Walking On A Flat Surface
Participants	PENNSAID Gel	Vehicle
None	0	1
Mild	8	4
Moderate	62	67
Severe	51	43
Extreme	9	14

PrimaryPain 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.

Time frame:: at Week 4
Reported as:: Count of participants · Participants

Pain When Walking On A Flat Surface
Participants	PENNSAID Gel	Vehicle
None	19	19
Mild	47	38
Moderate	45	51
Severe	11	10
Extreme	1	0

PrimaryPain 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.

Time frame:: at Baseline
Reported as:: Count of participants · Participants

Pain When Going Up Or Down Stairs
Participants	PENNSAID Gel	Vehicle
None	0	0
Mild	1	1
Moderate	14	14
Severe	80	84
Extreme	35	30

PrimaryPain 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.

Time frame:: at Week 4
Reported as:: Count of participants · Participants

Pain When Going Up Or Down Stairs
Participants	PENNSAID Gel	Vehicle
None	4	4
Mild	34	32
Moderate	51	37
Severe	29	40
Extreme	5	5

PrimaryPain 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.

Time frame:: at Baseline
Reported as:: Count of participants · Participants

Pain At Night While In Bed
Participants	PENNSAID Gel	Vehicle
None	5	6
Mild	23	26
Moderate	60	50
Severe	32	33
Extreme	9	14

PrimaryPain 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.

Time frame:: at Week 4
Reported as:: Count of participants · Participants

Pain At Night While In Bed
Participants	PENNSAID Gel	Vehicle
None	37	30
Mild	45	45
Moderate	34	35
Severe	5	8
Extreme	2	0

PrimaryPain 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.

Time frame:: at Baseline
Reported as:: Count of participants · Participants

Pain While Sitting Or Lying Down
Participants	PENNSAID Gel	Vehicle
None	1	4
Mild	30	22
Moderate	63	63
Severe	30	28
Extreme	6	12

PrimaryPain 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.

Time frame:: at Week 4
Reported as:: Count of participants · Participants

Pain While Sitting Or Lying Down
Participants	PENNSAID Gel	Vehicle
None	36	25
Mild	46	55
Moderate	36	34
Severe	5	4
Extreme	0	0

PrimaryPain 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.

Time frame:: at Baseline
Reported as:: Count of participants · Participants

Pain While Standing
Participants	PENNSAID Gel	Vehicle
None	0	2
Mild	7	6
Moderate	54	52
Severe	53	51
Extreme	16	18

PrimaryPain 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.

Time frame:: at Week 4
Reported as:: Count of participants · Participants

Pain While Standing
Participants	PENNSAID Gel	Vehicle
None	15	13
Mild	47	42
Moderate	49	50
Severe	11	11
Extreme	1	2

Adverse events

Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
PENNSAID Gel	0/130 (0%)	0/130 (0%)	45/130 (34.6%)
Vehicle	0/129 (0%)	0/129 (0%)	59/129 (45.7%)

Most frequent other events

Most frequent other events
Event	PENNSAID Gel	Vehicle
Application site drynessGeneral disorders	28/130	28/129
Application site pruritisGeneral disorders	3/130	18/129
Application site erythemaGeneral disorders	5/130	15/129
Application site exfoliationGeneral disorders	9/130	11/129

Baseline characteristics

Modified Intent-to-Treat (mITT) - all participants who were randomized and received study drug

Age, Continuous
Age, Continuous(years)	PENNSAID Gel	Vehicle	Total
Mean	60.2 ± 9.23	61.9 ± 9.07	61.1 ± 9.17

Sex: Female, Male
Sex: Female, Male(Participants)	PENNSAID Gel	Vehicle	Total
Female	84	90	174
Male	46	39	85

Region of Enrollment
Region of Enrollment(participants)	PENNSAID Gel	Vehicle	Total
United States	130	129	259

Study locations

26 sites

Genova Clinical Research
Tucson, Arizona 85741, United States
Benchmark Research
Sacramento, California 95816, United States
Tampa Bay Medical Research, Inc
Clearwater, Florida 33761, United States
Avail Clinical Research
DeLand, Florida 32724, United States
Comprehensive NeuroScience Inc.
St. Petersburg, Florida 33716, United States
Drug Studies America
Marietta, Georgia 30060, United States
South Coast Medical Group
Savannah, Georgia 31406, United States
Clinical Trials Technology, Inc.
Prairie Village, Kansas 66206, United States
Sterling Research
Erlanger, Kentucky 41018, United States
Radiant Research Inc.
St Louis, Missouri 63141, United States
Sundance Clinical Research
St Louis, Missouri 63141, United States
Clinical Study Center of Asheville
Asheville, North Carolina 28803, United States
Peters Medical Research, LLC
High Point, North Carolina 27262, United States
Crescent Medical Research
Salisbury, North Carolina 28144, United States
New Hanover Medical Research
Wilmington, North Carolina 28401, United States
Sterling Research
Cincinnati, Ohio 45246, United States
Radiant Research Inc.
Columbus, Ohio 43212, United States
Clinical Research Source, Inc.
Perrysburg, Ohio 43551, United States
Radiant Research Inc.
Anderson, South Carolina 29261, United States
Palmetto Medical Research
Mt. Pleasant, South Carolina 29464, United States
Holston Medical Group Clinical Research
Kingsport, Tennessee 37660, United States
Benchmark Research
Fort Worth, Texas 76135, United States
Benchmark Research
San Angelo, Texas 76904, United States
Sun Research Institute
San Antonio, Texas 78215, United States
Charlottesville Medical Research
Charlottesville, Virginia 22911, United States
HypotheTest, LLC
Roanoke, Virginia 24018, United States

References and documents

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 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01119898
Lead sponsor: Mallinckrodt
Responsible party: Sponsor
First posted: May 10, 2010
Start date: Aug 2, 2010
Primary completion: Feb 16, 2011
Completion: Feb 16, 2011
Results posted: Oct 22, 2019
Last update: Oct 22, 2019

Study contacts

Joseph Pierro, MD

study director · Mallinckrodt

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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