Exploratory Study of PENNSAID Gel to Treat Symptoms of Knee Osteoarthritis

NCT01119898 | Completed Phase 2 Results FDA Drug

• 1 other identifier: COV05100031
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 26

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.

Conditions

Osteoarthritis of the Knee

Keywords

Osteoarthritis; Arthritis; NSAIDs; Topical NSAID; Diclofenac; PENNSAID

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

PENNSAID Gel

EXPERIMENTAL

Diclofenac sodium 2.0% w/w

Drug: PENNSAID Gel

Vehicle

PLACEBO COMPARATOR

The complete carrier containing ingredients at the same concentrations as experimental arm without diclofenac sodium

Drug: Vehicle

Interventions

PENNSAID Gel DRUG

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

PENNSAID Gel

Vehicle DRUG

2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks

Vehicle

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mallinckrodt: lead

Study Sites (26)

Genova Clinical Research

Tucson, Arizona, 85741, United States

Location

Benchmark Research

Sacramento, California, 95816, United States

Location

Tampa Bay Medical Research, Inc

Clearwater, Florida, 33761, United States

Location

Avail Clinical Research

DeLand, Florida, 32724, United States

Location

Comprehensive NeuroScience Inc.

St. Petersburg, Florida, 33716, United States

Location

Drug Studies America

Marietta, Georgia, 30060, United States

Location

South Coast Medical Group

Savannah, Georgia, 31406, United States

Location

Clinical Trials Technology, Inc.

Prairie Village, Kansas, 66206, United States

Location

Sterling Research

Erlanger, Kentucky, 41018, United States

Location

Radiant Research Inc.

St Louis, Missouri, 63141, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

Clinical Study Center of Asheville

Asheville, North Carolina, 28803, United States

Location

Peters Medical Research, LLC

High Point, North Carolina, 27262, United States

Location

Crescent Medical Research

Salisbury, North Carolina, 28144, United States

Location

New Hanover Medical Research

Wilmington, North Carolina, 28401, United States

Location

Sterling Research

Cincinnati, Ohio, 45246, United States

Location

Radiant Research Inc.

Columbus, Ohio, 43212, United States

Location

Clinical Research Source, Inc.

Perrysburg, Ohio, 43551, United States

Location

Radiant Research Inc.

Anderson, South Carolina, 29261, United States

Location

Palmetto Medical Research

Mt. Pleasant, South Carolina, 29464, United States

Location

Holston Medical Group Clinical Research

Kingsport, Tennessee, 37660, United States

Location

Benchmark Research

Fort Worth, Texas, 76135, United States

Location

Benchmark Research

San Angelo, Texas, 76904, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

HypotheTest, LLC

Roanoke, Virginia, 24018, United States

Location

Related Publications (1)

• 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.

  PMID: 26506138 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Arthritis

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Medical Information Call Center
• Organization: Mallinckrodt Pharmaceuticals

clinicaltrials@mnk.com

800-556-3314

Study Officials

• Joseph Pierro, MD

  Mallinckrodt

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2010
• First Posted: May 10, 2010
• Study Start: August 2, 2010
• Primary Completion: February 16, 2011
• Study Completion: February 16, 2011
• Last Updated: October 22, 2019
• Results First Posted: October 22, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (26)