Exploratory Study of PENNSAID Gel to Treat Symptoms of Knee Osteoarthritis
NCT ID: NCT01119898
Last Updated: 2019-10-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
260 participants
INTERVENTIONAL
2010-08-02
2011-02-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Trial to See if Topical Pennsaid for Knee Pain Affects Coagulation Values in Patients Who Are Also Taking Anticoagulants
NCT01511939
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study In Subjects With Osteoarthritic Pain Of The Knee
NCT00689273
Efficacy and Safety of Diclofenac DDEA 2.32 % in Patient Suffering From Knee Osteoarthritis (OA)
NCT01967550
A Study to Evaluate the Safety and Efficacy of Topically Applied TV-45070 (Ointment) in Participants With Primary Osteoarthritis (OA) Affecting a Single Knee
NCT02068599
Trial Comparing Three Single Dose Injections for Knee Osteoarthritis
NCT05492851
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PENNSAID Gel
Diclofenac sodium 2.0% w/w
PENNSAID Gel
2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
Vehicle
The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium
Vehicle
2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PENNSAID Gel
2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
Vehicle
2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
40 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mallinckrodt
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joseph Pierro, MD
Role: STUDY_DIRECTOR
Mallinckrodt
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Genova Clinical Research
Tucson, Arizona, United States
Benchmark Research
Sacramento, California, United States
Tampa Bay Medical Research, Inc
Clearwater, Florida, United States
Avail Clinical Research
DeLand, Florida, United States
Comprehensive NeuroScience Inc.
St. Petersburg, Florida, United States
Drug Studies America
Marietta, Georgia, United States
South Coast Medical Group
Savannah, Georgia, United States
Clinical Trials Technology, Inc.
Prairie Village, Kansas, United States
Sterling Research
Erlanger, Kentucky, United States
Radiant Research Inc.
St Louis, Missouri, United States
Sundance Clinical Research
St Louis, Missouri, United States
Clinical Study Center of Asheville
Asheville, North Carolina, United States
Peters Medical Research, LLC
High Point, North Carolina, United States
Crescent Medical Research
Salisbury, North Carolina, United States
New Hanover Medical Research
Wilmington, North Carolina, United States
Sterling Research
Cincinnati, Ohio, United States
Radiant Research Inc.
Columbus, Ohio, United States
Clinical Research Source, Inc.
Perrysburg, Ohio, United States
Radiant Research Inc.
Anderson, South Carolina, United States
Palmetto Medical Research
Mt. Pleasant, South Carolina, United States
Holston Medical Group Clinical Research
Kingsport, Tennessee, United States
Benchmark Research
Fort Worth, Texas, United States
Benchmark Research
San Angelo, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
HypotheTest, LLC
Roanoke, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
COV05100031
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.