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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-12-31

Brief Summary

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

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Detailed Description

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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

Conditions

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Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Study treatment, 4975, is instilled directly into surgical site

Group Type EXPERIMENTAL

4975, highly purified capsaicin

Intervention Type DRUG

One dose administered by direct instillation into the surgical site

2

Placebo is instilled directly into surgical site

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

One dose administered by direct instillation into the surgical site

Interventions

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4975, highly purified capsaicin

One dose administered by direct instillation into the surgical site

Intervention Type DRUG

Placebo

One dose administered by direct instillation into the surgical site

Intervention Type DRUG

Other Intervention Names

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4975, Adlea

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No