Trial Outcomes & Findings for Trial to See if Topical Pennsaid for Knee Pain Affects Coagulation Values in Patients Who Are Also Taking Anticoagulants (NCT NCT01511939)
NCT ID: NCT01511939
Last Updated: 2014-06-26
Results Overview
PT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
22 participants
Primary outcome timeframe
Baseline to week 4
Results posted on
2014-06-26
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
5
|
8
|
|
Overall Study
COMPLETED
|
7
|
4
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
Baseline Characteristics
Trial to See if Topical Pennsaid for Knee Pain Affects Coagulation Values in Patients Who Are Also Taking Anticoagulants
Baseline characteristics by cohort
| Measure |
Pennsaid, Warfarin
n=9 Participants
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.
|
Pennsaid, Dabigatran
n=5 Participants
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.
|
Pennsaid, Aspirin and/or Clopidogrel
n=8 Participants
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.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
> / = 55 years
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
22 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
22 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 4Population: 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.
PT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.
Outcome measures
| Measure |
Pennsaid, Warfarin
n=7 Participants
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.
|
Pennsaid, Dabigatran
n=4 Participants
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.
|
Pennsaid, Aspirin and/or Clopidogrel
n=8 Participants
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.
|
|---|---|---|---|
|
Change From Baseline to Week 4 in Laboratory Results of Prothrombin Time (PT)
|
6.97 seconds
Interval 0.2 to 10.8
|
0.96 seconds
Interval -2.4 to 2.3
|
-0.04 seconds
Interval -0.8 to 0.7
|
PRIMARY outcome
Timeframe: Baseline to Week 4Population: 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.
INR will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.
Outcome measures
| Measure |
Pennsaid, Warfarin
n=7 Participants
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.
|
Pennsaid, Dabigatran
n=4 Participants
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.
|
Pennsaid, Aspirin and/or Clopidogrel
n=8 Participants
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.
|
|---|---|---|---|
|
Change From Baseline to Week 4 in Laboratory Results of International Normalized Ratio (INR)
|
0.63 ratio
Interval 0.01 to 1.0
|
0.09 ratio
Interval -0.21 to 0.2
|
0.00 ratio
Interval -0.07 to 0.07
|
PRIMARY outcome
Timeframe: Baseline to Week 4Population: 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.
PTT will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.
Outcome measures
| Measure |
Pennsaid, Warfarin
n=7 Participants
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.
|
Pennsaid, Dabigatran
n=4 Participants
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.
|
Pennsaid, Aspirin and/or Clopidogrel
n=8 Participants
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.
|
|---|---|---|---|
|
Change From Baseline to Week 4 in Laboratory Results of Partial Thromboplastin Time (PTT)
|
2.68 Seconds
Interval -1.2 to 6.3
|
1.50 Seconds
Interval -5.8 to 7.2
|
-0.29 Seconds
Interval -2.9 to 2.3
|
PRIMARY outcome
Timeframe: Baseline to Week 4Population: 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.
Platelet Aggregation will be evaluated to determine if there is any significant effect of Pennsaid on coagulation parameters.
Outcome measures
| Measure |
Pennsaid, Warfarin
n=7 Participants
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.
|
Pennsaid, Dabigatran
n=4 Participants
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.
|
Pennsaid, Aspirin and/or Clopidogrel
n=10 Participants
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.
|
|---|---|---|---|
|
Change From Baseline to Week 4 in Laboratory Results of Platelet Aggregation
|
8.14 Seconds
Interval -16.0 to 43.0
|
-39.25 Seconds
Interval -110.0 to -4.0
|
-13.30 Seconds
Interval -155.0 to 117.0
|
Adverse Events
Pennsaid, Warfarin
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Pennsaid, Dabigatran
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pennsaid, Aspirin and/or Clopidogrel
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pennsaid, Warfarin
n=9 participants at risk
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.
|
Pennsaid, Dabigatran
n=5 participants at risk
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.
|
Pennsaid, Aspirin and/or Clopidogrel
n=10 participants at risk
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.
|
|---|---|---|---|
|
General disorders
Epistaxis
|
11.1%
1/9 • Number of events 1
|
0.00%
0/5
|
0.00%
0/10
|
Other adverse events
| Measure |
Pennsaid, Warfarin
n=9 participants at risk
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.
|
Pennsaid, Dabigatran
n=5 participants at risk
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.
|
Pennsaid, Aspirin and/or Clopidogrel
n=10 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Bowel Impaction
|
11.1%
1/9 • Number of events 1
|
0.00%
0/5
|
0.00%
0/10
|
|
Vascular disorders
Swelling of lower extremities
|
11.1%
1/9 • Number of events 1
|
0.00%
0/5
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Epistaxis
|
11.1%
1/9 • Number of events 1
|
0.00%
0/5
|
0.00%
0/10
|
|
General disorders
Broken Tooth
|
11.1%
1/9 • Number of events 1
|
0.00%
0/5
|
0.00%
0/10
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1
|
0.00%
0/5
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/9
|
0.00%
0/5
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash on lower extremities
|
0.00%
0/9
|
0.00%
0/5
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.00%
0/9
|
0.00%
0/5
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Gastroenteritis
|
11.1%
1/9 • Number of events 1
|
0.00%
0/5
|
0.00%
0/10
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1
|
0.00%
0/5
|
0.00%
0/10
|
|
General disorders
Metallic taste in mouth
|
0.00%
0/9
|
0.00%
0/5
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Headache
|
0.00%
0/9
|
0.00%
0/5
|
10.0%
1/10 • Number of events 1
|
|
Endocrine disorders
Hyperglycemia
|
0.00%
0/9
|
0.00%
0/5
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/9
|
0.00%
0/5
|
10.0%
1/10 • Number of events 1
|
Additional Information
Manager, Clinical Research Department
Arthritis Treatment Center
Phone: 301-624-1168
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place