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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of a Single Intraoperative Localized Instillation of 4975 in Patients Undergoing Primary Unilateral Total Hip Arthroplasty

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00683267

Enrollment

118

Registered

2008-05-23

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

Arthroplasty

Keywords

THA, Total hip arthroplasty, total hip replacement

Brief summary

Evaluate the efficacy, safety and tolerability of a single intraoperative dose of 4975 in patients undergoing total hip replacement

Detailed description

The purpose of this study is to evaluate the efficacy, safety, and tolerability of a single intraoperative dose of 4975 in patients undergoing primary unilateral total hip arthroplasty

Interventions

DRUG4975, highly purified capsaicin

One dose administered by direct instillation into the surgical site

DRUGPlacebo

One dose administered by direct instillation into the surgical site

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Male or female aged 18 to 85 years with an American Society of Anesthesiologists (ASA) status of I, II, III * Planning to undergo unilateral THA * In good health and capable of undergoing THA with spinal block and sedation anesthesia * No additional planned surgeries during the course of the trial * Willing and able to complete the study procedures and pain scales and to communicate meaningfully in English Key

Exclusion criteria

* A body mass index greater than 40 * Known bleeding disorder or is taking agents affecting coagulation preoperatively * A medical condition that could adversely impact the patient's participation, safety, or conduct of the study * Diabetes mellitus with a known HbA1C\>9.5 or a history of prolonged uncontrolled diabetes * Previous hip arthroplasty of the same hip * Participated in another clinical trial within 30 days of the planned hip surgery

Design outcomes

Primary

Measure	Time frame
Numerical Rating Scale (NRS) measures of pain at prespecified times	Primary endpoint is 2 days (4-48 hours)

Secondary

Measure	Time frame
Other efficacy endpoints, safety and tolerability of 4975	42 Days

Countries

United States

Outcome results

None listed

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