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

NCT00683267 | Terminated Phase 2

• 1 other identifier: 114-03P
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Arthroplasty

Keywords

THA, Total hip arthroplasty, total hip replacement

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 endpoints, safety and tolerability of 4975

  42 Days

Study Arms (2)

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

4975, highly purified capsaicin DRUG

One dose administered by direct instillation into the surgical site

Also known as: 4975, Adlea

1

Placebo DRUG

One dose administered by direct instillation into the surgical site

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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, 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anesiva, Inc.: lead

Study Sites (10)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

Location

Lotus Clinical Research, Inc.

Arcadia, California, 91007, United States

Location

Glendale Adventist Medical Center

Glendale, California, 91206, United States

Location

Webster Orthopaedic Medical Group

Oakland, California, 94612, United States

Location

University of California at San Francisco - Mt. Zion

San Francisco, California, 94115, United States

Location

Coastal Medical Research, Inc.

Port Orange, Florida, 32127, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

William Beaumont Hospital

Troy, Michigan, 48085, United States

Location

Sewickley Valley Hospial

Sewickley, Pennsylvania, 15143, United States

Location

Covenant Medical Center

Lubbock, Texas, 79410, United States

Location

Related Links

• Anesiva Home page
• ADLEA Product Information

MeSH Terms

Interventions

ALGRX-4975

Study Officials

• Shaun Comfort, MD, MBA

  Anesiva, Inc.

  STUDY DIRECTOR

• William Houghton, MD

  Anesiva, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 23, 2008
• Study Start: September 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 4, 2009

Record last verified: 2009-05

Locations

US (10)