Exploratory Study of PENNSAID Gel to Treat Symptoms of Knee Osteoarthritis

Osteoarthritis of the Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01119898
• Other study ID #: COV05100031
• Status: Completed
• Phase: Phase 2
• Start date: August 2, 2010
• Est. completion date: February 16, 2011

Study information

• Verified date: October 2019
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: February 16, 2011
• Est. primary completion date: February 16, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Radiant Research Inc.	Anderson	South Carolina
United States	Clinical Study Center of Asheville	Asheville	North Carolina
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	Sterling Research	Cincinnati	Ohio
United States	Tampa Bay Medical Research, Inc	Clearwater	Florida
United States	Radiant Research Inc.	Columbus	Ohio
United States	Avail Clinical Research	DeLand	Florida
United States	Sterling Research	Erlanger	Kentucky
United States	Benchmark Research	Fort Worth	Texas
United States	Peters Medical Research, LLC	High Point	North Carolina
United States	Holston Medical Group Clinical Research	Kingsport	Tennessee
United States	Drug Studies America	Marietta	Georgia
United States	Palmetto Medical Research	Mount Pleasant	South Carolina
United States	Clinical Research Source, Inc.	Perrysburg	Ohio
United States	Clinical Trials Technology, Inc.	Prairie Village	Kansas
United States	HypotheTest, LLC	Roanoke	Virginia
United States	Benchmark Research	Sacramento	California
United States	Radiant Research Inc.	Saint Louis	Missouri
United States	Sundance Clinical Research	Saint Louis	Missouri
United States	Comprehensive NeuroScience Inc.	Saint Petersburg	Florida
United States	Crescent Medical Research	Salisbury	North Carolina
United States	Benchmark Research	San Angelo	Texas
United States	Sun Research Institute	San Antonio	Texas
United States	South Coast Medical Group	Savannah	Georgia
United States	Genova Clinical Research	Tucson	Arizona
United States	New Hanover Medical Research	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at Baseline
Primary	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.	at Week 4
Primary	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.	at Baseline
Primary	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.	at Week 4
Primary	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.	at Baseline
Primary	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.	at Week 4
Primary	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.	at Baseline
Primary	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.	at Week 4
Primary	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.	at Baseline
Primary	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.	at Week 4