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

A Phase 3, Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, Safety, and Pharmacokinetics of 4975 in Patients Undergoing Primary Unilateral Total Knee Arthroplasty

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00681356
Enrollment
214
Registered
2008-05-21
Start date
2007-09-30
Completion date
2008-12-31
Last updated
2009-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Arthroplasty (Replacement)

Keywords

TKA, Total knee arthroplasty, Total knee replacement, Knee surgery

Brief summary

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

Detailed 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

Interventions

DRUG4975, 15 and 5 mg

Direct instillation into the surgical site

DRUGPlacebo Comparator

Direct instillation into the surgical site

DRUG4975 - 5 mg

Direct instillation into the surgical site

Sponsors

Anesiva, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Numerical Rating Scale (NRS) measures of pain at prespecified timesPrimary endpoint is 2 days (4-48 hours)

Secondary

MeasureTime frame
Other efficacy parameters, safety and tolerability of 497542 Days or Early Termination

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026