Trial to See if Topical Pennsaid for Knee Pain Affects Coagulation Values in Patients Who Are Also Taking Anticoagulants

NCT01511939 | Completed Phase 3 Results

• 1 other identifier: ATCCTCP-1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if using a topical nonsteroidal antiinflammatory drug (Pennsaid) to treat osteoarthritis knee pain will affect coagulation values in patients who are also taking anticoagulant or antithrombotic medications.

Conditions

Osteoarthritis of the Knee; Coagulopathy

Keywords

Knee pain; Anticoagulant; Warfarin; Dabigatran; Clopidogrel; Aspirin; Topical NSAID; Osteoarthritis

Outcome Measures

Primary Outcomes (4)

• Change From Baseline to Week 4 in Laboratory Results of Prothrombin Time (PT)

  PT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.

  Baseline to week 4

• Change From Baseline to Week 4 in Laboratory Results of International Normalized Ratio (INR)

  INR will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.

  Baseline to Week 4

• Change From Baseline to Week 4 in Laboratory Results of Partial Thromboplastin Time (PTT)

  PTT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.

  Baseline to Week 4

• Change From Baseline to Week 4 in Laboratory Results of Platelet Aggregation

  Platelet Aggregation will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.

  Baseline to Week 4

Study Arms (3)

Pennsaid, warfarin

OTHER

Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months

Drug: Pennsaid

Pennsaid, dabigatran

OTHER

Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months

Drug: Pennsaid

Pennsaid, aspirin and/or clopidogrel

OTHER

Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months

Drug: Pennsaid

Interventions

Pennsaid DRUG

Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis pain is present bilaterally) 4 times a day for a 4 week active treatment period.

Also known as: Pennsaid 1.5%, Diclofenac sodium 1.5% topical solution, Topical nonsteroidal antiinflammatory drug, Topical NSAID

Pennsaid, aspirin and/or clopidogrel; Pennsaid, dabigatran; Pennsaid, warfarin

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adults \> than or equal to 55
• Ambulatory subjects with moderate to severe osteoarthritis (OA) of the knee with symptoms and knee pain for at least 3 months and pain on the majority of days in the last 30 days.
• Subjects with bilateral knee OA, the more symptomatic knee is the index knee and PENNSAID can be applied on both knees if both are affected.
• Radiographic evidence of Kellgren-Lawrence Grade 2-4 within the past 2 years.
• Currently on a stable dose of anticoagulant therapy (warfarin, dabigatran, aspirin or clopidogrel) for the past 2 months and expected to remain on current dose for the six week duration of the study.
• If currently taking oral nonsteroidal antiinflammatory drug (NSAID) and/or acetaminophen for OA knee pain, must be taking it for at least an average of 25 days per month.
• Those currently taking oral NSAID must be willing to perform a 7 day washout to be eligible to be enrolled into the study.
• A pain score of \> than 40mm on the Patient Pain Visual Analog Scale (VAS) (100 mm scale) at screening and baseline visit.
• Able to comply with the study and give informed consent prior to performance of any study procedures.
• Able to read, write and understand English.

You may not qualify if:

• Unwilling to abstain from oral NSAIDs and/or other analgesic medication except for acetaminophen as rescue medication. Subjects taking low dose aspirin for cardiovascular health may remain on their stable dose throughout the study.
• Unwilling to abstain from taking \< than or equal to 1500mg of acetaminophen a day for rescue medication purposes during the 6 week course of the trial.
• Using a handicap assistance device i.e. cane, walker \> than or equal to 50% of the time.
• Undergoing new physical therapy or participating in a weight loss or exercise program that has not been stable for at least 3 months prior to screening and won't remain stable during participation in study.
• History or diagnosis of an inflammatory arthritis i.e. rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis, or amyloidosis.
• Known or clinically suspected infection and human immunodeficiency virus (HIV), or hepatitis C or B viruses.
• History of abnormal laboratory results \> that or equal to 2.5 x upper limit of normal (ULN) indicative of any significant medical disease which in the opinion of the investigator, would preclude the subjects participation in the study.
• Any of the following abnormal laboratory results during screening:
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> than or equal to 2.5 x ULN
• Hemoglobin \< than 11.5 g/dL (female) or \< 13.2 g/dL (male)
• White blood cell count (WBC) \< than 3500 cells/mm3
• Lymphocyte count \< than or equal to 1000 cels/mm3
• Serum creatinine \> than or equal 1.5 x ULN
• Platelet count below the central laboratory lower limit of normal (LLN)
• Coagulation tests (Prothrombin Time (PT), Partial Thromboplastin Time (PTT), International Normalized Ratio (INR), Platelet Aggregation) requiring an alteration in anticoagulant dosage.

Sponsors & Collaborators

• Nathan Wei, MD, FACP, FACR: lead
• Medtronic - MITG: collaborator
• Arthritis Treatment Center, Maryland: collaborator

Study Sites (1)

Arthritis Treatment Center

Frederick, Maryland, 21702, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Hemostatic Disorders; Osteoarthritis

Interventions

Diclofenac; Solutions; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Pharmaceutical Preparations; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Results Point of Contact

• Title: Manager, Clinical Research Department
• Organization: Arthritis Treatment Center

tgillis@arthritistreatmentcenter.com

301-624-1168

Study Officials

• Nathan Wei, MD,FACP,FACR

  Arthritis Treatment Center, Frederick, Maryland, United States, 21702

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Nathan Wei, MD, FACP, FACR

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 19, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 26, 2014
• Results First Posted: June 26, 2014

Record last verified: 2014-06

Locations

US (1)