Safety and Efficacy Study of 4975 in Patients Undergoing Total Knee Replacement

Anesiva

Status and phase: Completed; Phase 3

Conditions: Total Knee Arthroplasty (Replacement)

Treatments: Drug: 4975 - 5 mg; Drug: Placebo Comparator; Drug: 4975, 15 and 5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00681356

114-01P

Details and patient eligibility

About

Evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing total knee replacement

Full description

The purpose of this study is to evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing primary unilateral total knee arthroplasty

Enrollment: 214 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male or female aged 18 to 85 years with an American Society of Anesthesiologists (ASA) status of I, II, or III
• Planning to undergo primary unilateral Total Knee Arthroplasty (TKA)

Key Exclusion Criteria:

• A body mass index (BMI) greater than 43
• Known bleeding disorder or is taking agents affecting coagulation preoperatively
• Use of medications or a medical condition that in the investigator's opinion could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments
• Diabetes mellitus with a known HbA1C>9.5 or a history of prolonged uncontrolled diabetes
• Previous knee arthroplasty (partial or total) of the same knee
• Participated in another clinical trial within 30 days prior to the planned TKA surgery

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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214 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

4975 - 15 mg

Treatment:

Drug: 4975, 15 and 5 mg

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo Comparator

3

Experimental group

Description:

4975 - truncated for Phase 3

Treatment:

Drug: 4975 - 5 mg