Trial to See if Topical Pennsaid for Knee Pain Affects Co... | NCT01511939

NCT01511939

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Medtronic - MITG	INDUSTRY
Arthritis Treatment Center, Maryland	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Skin breakdown or rash at knee where topical PENNSAID is to be applied.
Other serious uncontrolled non-malignant, significant, acute or chronic medical or psychiatric illness that, in judgment of investigator, could compromise subject safety, limit subject's ability to complete study and/or compromise the objectives of study.
History of malignancy in the past 5 years with exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ.
History of drug or alcohol dependence or abuse in the past 3 years.

Name	Affiliation	Role
Nathan Wei, MD,FACP,FACR	Arthritis Treatment Center, Frederick, Maryland, United States, 21702	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Arthritis Treatment Center		Frederick	Maryland	21702	United States

Arm/Group Information

ID	Title	Description
FG000	Pennsaid, Warfarin	Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis (OA) 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 Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period.
FG001	Pennsaid, Dabigatran	Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA 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 Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period.
FG002	Pennsaid, Aspirin and/or Clopidogrel	Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA 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 Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Pennsaid, Warfarin	Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA 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 Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Customized			Number

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Two subjects who completed the study were taking both an anticoagulant medication and aspirin. For this analysis, the subject who was taking warfarin and aspirin was included only in the "Pennsaid, warfarin" group, and the subject who was taking dabigatran and aspirin was included only in the "Pennsaid, dabigatran" group.

Posted

Mean

Full Range

seconds

Baseline to week 4

ID	Title	Description
OG000	Pennsaid, Warfarin	Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA 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 Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pennsaid, Warfarin	Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA 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 Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Epistaxis	General disorders			Epistaxis resulting in hospitalization and blood transfusion; assessed by Principal Investigator as not related to Pennsaid because patient had a history of sinus surgery which has resulted in a history of occasional severe epistaxis.

ID	Term
D020370	Osteoarthritis, Knee
D020141	Hemostatic Disorders
D010003	Osteoarthritis

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

ID	Term
D004008	Diclofenac
D012996	Solutions
D000894	Anti-Inflammatory Agents, Non-Steroidal

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals