Total Knee Arthroplasty (Replacement)Phase 3NCT00681356
Safety and Efficacy Study of 4975 in Patients Undergoing Total Knee Replacement
A Phase 3 study testing 4975, 15 and 5 mg and 4975 - 5 mg in people with Total Knee Arthroplasty (Replacement), run by Anesiva, Inc. at 25 sites in United States.
Trial summary
Evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing total knee replacement Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Total Knee Arthroplasty (Replacement)
- What is being tested?
- 4975, 15 and 5 mg and 4975 - 5 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 25 sitesUnited States
- Study dates
- Sep 2007to Dec 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- A body mass index (BMI) greater than 43
- Known bleeding disorder or is taking agents affecting coagulation preoperatively
- Use of medications or a medical condition that in the investigator's opinion could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments
- Diabetes mellitus with a known HbA1C>9.5 or a history of prolonged uncontrolled diabetes
- Previous knee arthroplasty (partial or total) of the same knee
- Participated in another clinical trial within 30 days prior to the planned TKA surgery
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235
Rush University Medical Center
Chicago, Illinois, 60612
Cleveland Clinic
Cleveland, Ohio, 44195
Presbyterian Hospital of Dallas
Dallas, Texas, 75231
Florida Hospital - Florida Research Associates, LLC
DeLand, Florida, 32720
Glendale Adventist Medical Center - Lotus Clinical Research
Glendale, California, 91206
Orthopedic Associates of Hartford
Hartford, Connecticut, 06106
Memorial City Hospital - Memorial Hermann Healthcare System
Houston, Texas, 77024
Physicians Clinical Research Corporation
Laguna Hills, California, 92653
Saddleback Memorial Medical Center/Accurate Clinical Trials
Laguna Hills, California, 92653
University of Miami, Miller School of Medicine
Miami, Florida, 33136
Miami Institute for Medical Research
Miami, Florida, 33186
Springhill Medical Center
Mobile, Alabama, 36608
Webster Orthopeadic Medical Group
Oakland, California, 94612
Southeastern Clinical Research Consultants
Orlando, Florida, 32804
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Coastal Medical Research
Port Orange, Florida, 32127
Oregon Health & Science University
Portland, Oregon, 97239
William Beaumont Hospital
Royal Oak, Michigan, 48085
UCSF-Mt. Zion Medical Center
San Francisco, California, 94115
Sewickley Valley Hospital
Sewickley, Pennsylvania, 15143
Hellen Keller Hospital
Sheffield, Alabama, 35660
Ruxton Professional Center - Orthopaedic Associates
Towson, Maryland, 21204
William Beaumont Hospital
Troy, Michigan, 48085
Visions Clinical Research/Tucson Medical Center
Tucson, Arizona, 85712
About this study
Official title: A Phase 3, Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, Safety, and Pharmacokinetics of 4975 in Patients Undergoing Primary Unilateral Total Knee Arthroplasty
Evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing total knee replacement
Read the detailed description
The purpose of this study is to evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing primary unilateral total knee arthroplasty
- Conditions
- Total Knee Arthroplasty (Replacement)
- Being tested
- 4975, 15 and 5 mg, Placebo Comparator, 4975 - 5 mg
- Keywords
- TKA, Total knee arthroplasty, Total knee replacement, Knee surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4975, 15 and 5 mgDrug
Also called Adlea
Direct instillation into the surgical site
Placebo ComparatorDrug
Direct instillation into the surgical site
4975 - 5 mgDrug
Direct instillation into the surgical site
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 4975 - 15 mg Receives: Drug: 4975, 15 and 5 mg |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo Comparator |
| 3 | Experimental | 4975 - truncated for Phase 3 Receives: Drug: 4975 - 5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS) measures of pain at prespecified times
Measured: Primary endpoint is 2 days (4-48 hours)
Secondary outcomes (1)
Other efficacy parameters, safety and tolerability of 4975
Measured: 42 Days or Early Termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startSep 2007
- Primary completionSep 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee Arthroplasty (Replacement)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anesiva, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shaun Comfort, MD, Study director, Anesiva, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681356
- Sponsor's protocol ID
- 114-01P
- Status last verified
- May 2009
- First submitted
- 16 May 2008
- Last updated
- 4 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21971213
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, Safety, and Pharmacokinetics of 4975 in Patients Undergoing Primary Unilateral Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00681356
- Acronym / sponsor ID
- 114-01P
- Conditions
- Total Knee Arthroplasty (Replacement)
- Keywords
- TKA, Total knee arthroplasty, Total knee replacement, Knee surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Anesiva, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 21 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing total knee replacement
Detailed description
The purpose of this study is to evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing primary unilateral total knee arthroplasty
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 4975, 15 and 5 mg4975 - 15 mg |
| 2 | Placebo comparator | Drug: Placebo ComparatorPlacebo |
| 3 | Experimental | Drug: 4975 - 5 mg4975 - truncated for Phase 3 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- A body mass index (BMI) greater than 43
- Known bleeding disorder or is taking agents affecting coagulation preoperatively
- Use of medications or a medical condition that in the investigator's opinion could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments
- Diabetes mellitus with a known HbA1C>9.5 or a history of prolonged uncontrolled diabetes
- Previous knee arthroplasty (partial or total) of the same knee
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4975, 15 and 5 mgAlso: AdleaDirect instillation into the surgical site | Drug | 1 |
| Placebo ComparatorDirect instillation into the surgical site | Drug | 2 |
| 4975 - 5 mgDirect instillation into the surgical site | Drug | 3 |
Primary outcome
Numerical Rating Scale (NRS) measures of pain at prespecified times
Time frame: Primary endpoint is 2 days (4-48 hours)
1 secondary outcome
Other efficacy parameters, safety and tolerability of 4975
Time frame: 42 Days or Early Termination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2009.
- Derived from this study: PubMed 21971213Hartrick 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.
- Anesiva, Inc. Home PageLink provided by the sponsor.
- ADLEA Product InformationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaun Comfort, MD study director
Anesiva, Inc.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 4975, 15 and 5 mg and 4975 - 5 mg in people with Total Knee Arthroplasty (Replacement), run by Anesiva, Inc. at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) measures of pain at prespecified times (time frame: Primary endpoint is 2 days (4-48 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00681356, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2009; AzTrials last refreshed its copy on 7 Nov 2026.