Osteoarthritis of the KneePhase 3ATCCTCP-1NCT01511939

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

A Phase 3 study testing Pennsaid in people with Osteoarthritis of the Knee and Coagulopathy, run by Nathan Wei, MD, FACP, FACR: at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 55 years and older
Conditions the study is for: Osteoarthritis of the Knee, Coagulopathy
What is being tested?: Pennsaid
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited States
Study dates: Feb 2012to May 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 10Show fewer

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.

Who cannot join

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.

Show all 19Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Arthritis Treatment Center
Frederick, Maryland, 21702

Other trials in United States

About this study

Official title: Single Center, Open-label Study of Effect of PENNSAID (Diclofenac Sodium Solution Topical) on Coagulation Parameters (PT, PTT, INR and Platelet Function) in Patients With Moderate to Severe Osteoarthritis Pain of the Knee Taking Anticoagulant Medication

Read the detailed description

Open-label active treatment Phase III study of Pennsaid (diclofenac sodium 1.5% topical solution) to determine the effects on coagulation parameters in patients who are equal to or greater than 55 years of age with moderate to severe osteoarthritis knee pain and who are also taking warfarin, dabigatran, or aspirin and/or clopidogrel.

Conditions: Osteoarthritis of the Knee, Coagulopathy
Being tested: Pennsaid
Keywords: Knee pain, Anticoagulant, Warfarin, Dabigatran, Clopidogrel, Aspirin, Topical NSAID, Osteoarthritis
Medical subject headings: Osteoarthritis, Knee, Hemostatic Disorders, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PennsaidDrug
Also called Pennsaid 1.5%, Diclofenac sodium 1.5% topical solution, Topical nonsteroidal antiinflammatory drug, Topical NSAID
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.

Study groups in NCT01511939
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: Drug: Pennsaid

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012May 2013

First posted19 Jan 2012 (estimated)
Study startFeb 2012
Primary completionMay 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01511939
Sponsor's protocol ID: ATCCTCP-1
Acronym: ATCCTCP-1
Status last verified: Jun 2014
First submitted: 9 Jan 2012
Last updated: 26 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

All Osteoarthritis of the Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single Center, Open-label Study of Effect of PENNSAID (Diclofenac Sodium Solution Topical) on Coagulation Parameters (PT, PTT, INR and Platelet Function) in Patients With Moderate to Severe Osteoarthritis Pain of the Knee Taking Anticoagulant Medication
ClinicalTrials.gov ID: NCT01511939
Acronym / sponsor ID: ATCCTCP-1 / ATCCTCP-1
Conditions: Osteoarthritis of the Knee, Coagulopathy
Keywords: Knee pain, Anticoagulant, Warfarin, Dabigatran, Clopidogrel, Aspirin, Topical NSAID, Osteoarthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Nathan Wei, MD, FACP, FACR:University, hospital or other
Collaborators: Medtronic - MITG, Arthritis Treatment Center, Maryland
Study start: Feb 2012
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 19 Jan 2012 (estimated)
Results: Posted 26 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Pennsaid, warfarin	Other	Drug: PennsaidPennsaid 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
Pennsaid, dabigatran	Other	Drug: PennsaidPennsaid 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
Pennsaid, aspirin and/or clopidogrel	Other	Drug: PennsaidPennsaid 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

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PennsaidAlso: Pennsaid 1.5%, Diclofenac sodium 1.5% topical solution, Topical nonsteroidal antiinflammatory drug, Topical NSAIDAdministered 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.	Drug	Pennsaid, aspirin and/or clopidogrel, Pennsaid, dabigatran, Pennsaid, warfarin

Primary outcome

Change From Baseline to Week 4 in Laboratory Results of Prothrombin Time (PT)
Time frame: Baseline to week 4
PT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.
Change From Baseline to Week 4 in Laboratory Results of International Normalized Ratio (INR)
Time frame: Baseline to Week 4
INR will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.
Change From Baseline to Week 4 in Laboratory Results of Partial Thromboplastin Time (PTT)
Time frame: Baseline to Week 4
PTT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.
Change From Baseline to Week 4 in Laboratory Results of Platelet Aggregation
Time frame: Baseline to Week 4
Platelet Aggregation will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.

Results and safety

Results posted to the registry on 26 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pennsaid, Warfarin	9	7
Pennsaid, Dabigatran	5	4
Pennsaid, Aspirin and/or Clopidogrel	8	8

Primary outcome: Change From Baseline to Week 4 in Laboratory Results of Prothrombin Time (PT)

Time frame: Baseline to week 4. Mean (Full Range). Unit: seconds

Measure	Pennsaid, Warfarin n = 7	Pennsaid, Dabigatran n = 4	Pennsaid, Aspirin and/or Clopidogrel n = 8
Value	6.97 (0.20 to 10.80)	0.96 (-2.40 to 2.30)	-0.04 (-0.80 to 0.70)

Population analysed: 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.

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

Time frame: Baseline to Week 4. Mean (Full Range). Unit: ratio

Measure	Pennsaid, Warfarin n = 7	Pennsaid, Dabigatran n = 4	Pennsaid, Aspirin and/or Clopidogrel n = 8
Value	0.63 (0.01 to 1.00)	0.09 (-0.21 to 0.20)	0.00 (-0.07 to 0.07)

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

Time frame: Baseline to Week 4. Mean (Full Range). Unit: Seconds

Measure	Pennsaid, Warfarin n = 7	Pennsaid, Dabigatran n = 4	Pennsaid, Aspirin and/or Clopidogrel n = 8
Value	2.68 (-1.20 to 6.30)	1.50 (-5.80 to 7.20)	-0.29 (-2.90 to 2.30)

Primary outcome: Change From Baseline to Week 4 in Laboratory Results of Platelet Aggregation

Time frame: Baseline to Week 4. Mean (Full Range). Unit: Seconds

Measure	Pennsaid, Warfarin n = 7	Pennsaid, Dabigatran n = 4	Pennsaid, Aspirin and/or Clopidogrel n = 10
Value	8.14 (-16.00 to 43.00)	-39.25 (-110.00 to -4.00)	-13.30 (-155.00 to 117.00)

Population analysed: For this analysis, the subject who was taking warfarin and aspirin was included in both the "Pennsaid, warfarin" group and the "Pennsaid, aspirin and/or clopidogrel" group, and the subject who was taking dabigatran and aspirin was included in both the "Pennsaid, dabigatran" group and the "Pennsaid, aspirin and/or clopidogrel" group.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pennsaid, Warfarin	1 of 9 (11.1%)	6 of 9 (66.7%)	Not reported
Pennsaid, Dabigatran	0 of 5 (0%)	0 of 5 (0%)	Not reported
Pennsaid, Aspirin and/or Clopidogrel	0 of 10 (0%)	4 of 10 (40%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Osteoarthritis of the Knee

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nathan Wei, MD,FACP,FACR principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pennsaid in people with Osteoarthritis of the Knee and Coagulopathy, run by Nathan Wei, MD, FACP, FACR: at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 4 in Laboratory Results of Prothrombin Time (PT) (time frame: Baseline to week 4). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01511939.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2014.