Trials Sponsors Conditions Drugs Pricing

Conditions

Total Knee Arthroplasty (Replacement)

Keywords

TKATotal knee arthroplastyTotal knee replacementKnee surgery

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

Other efficacy parameters, safety and tolerability of 4975
42 Days or Early Termination

Study Arms (3)

1

EXPERIMENTAL

4975 - 15 mg

Drug: 4975, 15 and 5 mg

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo Comparator

3

EXPERIMENTAL

4975 - truncated for Phase 3

Drug: 4975 - 5 mg

Interventions

4975, 15 and 5 mgDrug

Direct instillation into the surgical site

Also known as: Adlea

Placebo ComparatorDrug

Direct instillation into the surgical site

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

You may not qualify if:

Sponsors & Collaborators

Anesiva, Inc.
Industrylead

Study Sites (25)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

Springhill Medical Center

Mobile, Alabama, 36608, United States

Hellen Keller Hospital

Sheffield, Alabama, 35660, United States

Visions Clinical Research/Tucson Medical Center

Tucson, Arizona, 85712, United States

Glendale Adventist Medical Center - Lotus Clinical Research

Glendale, California, 91206, United States

Physicians Clinical Research Corporation

Laguna Hills, California, 92653, United States

Saddleback Memorial Medical Center/Accurate Clinical Trials

Related Publications (1)

Hartrick CT, Pestano C, Carlson N, Hartrick S. Capsaicin instillation for postoperative pain following total knee arthroplasty: a preliminary report of a randomized, double-blind, parallel-group, placebo-controlled, multicentre trial. Clin Drug Investig. 2011 Dec 1;31(12):877-82. doi: 10.1007/BF03256925.
PMID: 21971213DERIVED

MeSH Terms

Interventions

ALGRX-4975

Study Officials

Shaun Comfort, MD
Anesiva, Inc.
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: SUPPORTIVE CARE
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

May 16, 2008

First Posted

May 21, 2008

Study Start

September 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2008

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (25)

Related Publications (1)

Related Links

MeSH Terms

Interventions

Study Officials

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (25)

Related Publications (1)

Related Links

MeSH Terms

Interventions

Study Officials

Study Design

Study Record Dates

Source record

Locations