Recent Updates
Recently added Catalysts

Pennsaid

Phase 3

Osteoarthritis of the Knee | Small molecule | Musculoskeletal |Medtronic plc.|Last Updated: Jun 26, 2014

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

Pennsaid · 1 trial · 2 indications

Phase 3 1
NCT01511939Trial to See if Topical Pennsaid for Knee Pain Affects Coagulation Values in Patients Who Are Also Taking AnticoagulantsOsteoarthritis of the Knee
COMPLETED22 Analytics
PHASE3COMPLETED
Trial to See if Topical Pennsaid for Knee Pain Affects Coagulation Values in Patients Who Are Also Taking Anticoagulants
Osteoarthritis of the KneeUnlock trial analytics

Study Endpoints

Primary Endpoints

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

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

Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeSUPPORTIVE_CARE

Treatment Arms

ArmTypeDescription
Pennsaid, warfarinOTHERPennsaid 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, dabigatranOTHERPennsaid 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 clopidogrelOTHERPennsaid 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

Interventions

NameTypeDescription
PennsaidDRUGAdministered 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.
Unlock Study Design Details

Eligibility Criteria

Age Range55 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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 sympto...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Pennsaid

What is Pennsaid used for?

Pennsaid is used for osteoarthritis of the knee. It is a small molecule being developed by Medtronic plc. (MDT) as a topical treatment for knee pain associated with this condition.

What does Pennsaid target?

Pennsaid targets pain and inflammation in the knee joint through topical application. It is designed to deliver medication directly to the affected area to manage symptoms of osteoarthritis of the knee.

Who makes Pennsaid?

Pennsaid is being developed by Medtronic plc., which trades under the ticker MDT. The company is conducting clinical trials to evaluate the drug for osteoarthritis of the knee.

What phase is Pennsaid in?

Pennsaid is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed.

What clinical trials is Pennsaid in?

Pennsaid has one completed Phase 3 trial, NCT01511939, which studied the drug's effect on coagulation values in patients with knee osteoarthritis who also take anticoagulants. The trial enrolled 22 participants in the United States.

Is Pennsaid the same as other names?

Pennsaid is the primary name for this drug. No alternative names have been reported in clinical trial records. It is being studied specifically for osteoarthritis of the knee.