Efficacy and Safety Study of 4975 in Patients Undergoing... | NCT00683267

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Enrollment of patients has halted prematurely and will not resume. No future patients will be enrolled or treated.

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Nov 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

May 21, 2008

First Submission Date that Met QC Criteria

May 21, 2008

First Posted Date

May 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2009

Last Update Posted Date

May 4, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

118Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Study treatment, 4975, is instilled directly into surgical site	Drug: 4975, highly purified capsaicin
2	Placebo Comparator	Placebo is instilled directly into surgical site	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
4975, highly purified capsaicin	Drug	One dose administered by direct instillation into the surgical site	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shaun Comfort, MD, MBA	Anesiva, Inc.	Study Director
William Houghton, MD	Anesiva, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alabama Clinical Therapeutics, LLC		Birmingham	Alabama	35235	United States
Lotus Clinical Research, Inc.

Label	URL
Anesiva Home page	View source
ADLEA Product Information	View source

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms