Clinical trial NCT01119898: Exploratory Study of PENNSAID Gel to Treat Symptoms of Knee Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis
Arthritis
NSAIDs
Topical NSAID
Diclofenac
PENNSAID
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2010-05-10
Enrollment: 260
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Primary osteoarthritis of the knee
2. Radiologic evidence of OA of the knee
3. On stable pain therapy with an oral or topical NSAID or acetaminophen
4. Experience a "moderate flare" of pain following washout of stable pain therapy
5. Able to read and understand English or Spanish to answer pain assessment questions without any explanation
6. If female, surgically sterile or non-pregnant
7. Except for OA, in reasonably good general health
8. Written informed consent

Exclusion Criteria:

1. Secondary OA of the study knee
2. History of pseudo gout or inflammatory flare-ups
3. Participation would conflict with contraindications, warnings or precautions as stated in the prescribing information for oral or topical diclofenac
4. Severe, uncontrolled cardiac, renal, hepatic, or other systemic disease
5. Any malignancy within the previous 3 years, except local therapy for superficial skin cancer not on the study knee
6. Known sensitivity to the use of oral or topical diclofenac, aspirin \[acetylsalicylic acid (ASA)\] or any other NSAID, dimethyl sulfoxide (DMSO), or ethanol
7. Ongoing abnormality that could confound interpretation of the safety results (eg, anemia, unresponsive gastrointestinal \[GI\] reflux, etc.)
8. Documented gastroduodenal ulcer or any GI bleeding (except hemorrhoidal) within the last 6 months
9. Uncontrolled diabetes
10. 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
11. Documented alcohol or drug abuse within 1 year
12. If female, breast-feeding
13. Major surgery or previous damage to the study knee at any time, or minor knee surgery to the study knee within 1 year
14. 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
15. Received intra-articular viscosupplementation (eg, hylan G-F 20 \[Synvisc®\]) in the study knee in the past 6 months
16. 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.
17. Recently started taking a sedative hypnotic medication for insomnia
18. Taking anti-depressants
19. Not willing to discontinue prohibited medications/therapies
20. Cannot tolerate acetaminophen
21. Re-entering study after dropping out or withdrawn from study
22. Used another investigational drug within the previous 30 days
23. On or currently applying for disability benefits on the basis of knee OA
24. History of fibromyalgia
25. Other painful or disabling conditions affecting the knee or leg, or disabling condition of the hands (used to apply the study drug)
26. Skin disorder with current involvement on the hands (used to apply the study drug) or the knee(s) (application site)
27. Referred to an orthopedic surgeon for consideration of, or been advised to have, knee replacement or knee reconstruction surgery
28. Radiologic evidence of OA of the knee advanced to the point that all cartilage has been eroded (ie, bone on bone)
29. Recently started using a cane within the past 30 days
30. History of chronic headaches that may require more than occasional use of rescue medication for headaches

Primary outcomes:
measure: Pain When Walking On A Flat Surface
timeFrame: at Baseline
measure: Pain When Walking On A Flat Surface
timeFrame: at Week 4
measure: Pain When Going Up Or Down Stairs
timeFrame: at Baseline
measure: Pain When Going Up Or Down Stairs
timeFrame: at Week 4
measure: Pain At Night While In Bed
timeFrame: at Baseline
measure: Pain At Night While In Bed
timeFrame: at Week 4
measure: Pain While Sitting Or Lying Down
timeFrame: at Baseline
measure: Pain While Sitting Or Lying Down
timeFrame: at Week 4
measure: Pain While Standing
timeFrame: at Baseline
measure: Pain While Standing
timeFrame: at Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Genova Clinical Research
state: Arizona
city: Sacramento
country: United States
facility: Benchmark Research
state: California
city: Clearwater
country: United States
facility: Tampa Bay Medical Research, Inc
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research
state: Florida
city: Saint Petersburg
country: United States
facility: Comprehensive NeuroScience Inc.
state: Florida
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Savannah
country: United States
facility: South Coast Medical Group
state: Georgia
city: Prairie Village
country: United States
facility: Clinical Trials Technology, Inc.
state: Kansas
city: Erlanger
country: United States
facility: Sterling Research
state: Kentucky
city: Saint Louis
country: United States
facility: Radiant Research Inc.
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Asheville
country: United States
facility: Clinical Study Center of Asheville
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research, LLC
state: North Carolina
city: Salisbury
country: United States
facility: Crescent Medical Research
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Medical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Sterling Research
state: Ohio
city: Columbus
country: United States
facility: Radiant Research Inc.
state: Ohio
city: Perrysburg
country: United States
facility: Clinical Research Source, Inc.
state: Ohio
city: Anderson
country: United States
facility: Radiant Research Inc.
state: South Carolina
city: Mount Pleasant
country: United States
facility: Palmetto Medical Research
state: South Carolina
city: Kingsport
country: United States
facility: Holston Medical Group Clinical Research
state: Tennessee
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Roanoke
country: United States
facility: HypotheTest, LLC
state: Virginia
Study officials:
affiliation: Mallinckrodt
name: Joseph Pierro, MD
role: STUDY_DIRECTOR
References:
citation: 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.