ArthroplastyPhase 2NCT00683267
Efficacy and Safety Study of 4975 in Patients Undergoing Total Hip Replacement
A Phase 2 study testing 4975, highly purified capsaicin in people with Arthroplasty, run by Anesiva, Inc. at 10 sites in United States.
Trial summary
Evaluate the efficacy, safety and tolerability of a single intraoperative dose of 4975 in patients undergoing total hip replacement Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Arthroplasty
- What is being tested?
- 4975, highly purified capsaicin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 10 sitesUnited States
- Study dates
- Sep 2007to Dec 2008
- Phase
- Phase 2
- 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, 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Lotus Clinical Research, Inc.
Arcadia, California, 91007
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235
Glendale Adventist Medical Center
Glendale, California, 91206
Covenant Medical Center
Lubbock, Texas, 79410
Webster Orthopaedic Medical Group
Oakland, California, 94612
Coastal Medical Research, Inc.
Port Orange, Florida, 32127
William Beaumont Hospital
Royal Oak, Michigan, 48073
University of California at San Francisco - Mt. Zion
San Francisco, California, 94115
Sewickley Valley Hospial
Sewickley, Pennsylvania, 15143
William Beaumont Hospital
Troy, Michigan, 48085
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of a Single Intraoperative Localized Instillation of 4975 in Patients Undergoing Primary Unilateral Total Hip Arthroplasty
Evaluate the efficacy, safety and tolerability of a single intraoperative dose of 4975 in patients undergoing total hip replacement
Read the 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
- Conditions
- Arthroplasty
- Being tested
- 4975, highly purified capsaicin, Placebo
- Keywords
- THA, Total hip arthroplasty, total hip replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4975, highly purified capsaicinDrug
Also called 4975, Adlea
One dose administered by direct instillation into the surgical site
PlaceboDrug
One dose administered by direct instillation into the surgical site
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Study treatment, 4975, is instilled directly into surgical site Receives: Drug: 4975, highly purified capsaicin |
| 2 | Placebo comparator | Placebo is instilled directly into surgical site Receives: Drug: Placebo |
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 endpoints, safety and tolerability of 4975
Measured: 42 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startSep 2007
- Primary completionNov 2008
- Study completionDec 2008
Why it stopped: Enrollment of patients has halted prematurely and will not resume. No future patients will be enrolled or treated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroplastyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anesiva, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shaun Comfort, MD, MBA, Study director, Anesiva, Inc.William Houghton, MD, Study director, Anesiva, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00683267
- Sponsor's protocol ID
- 114-03P
- Status last verified
- May 2009
- First submitted
- 21 May 2008
- Last updated
- 4 May 2009
- Results posted
- No
- Data monitoring committee
- No
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 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of a Single Intraoperative Localized Instillation of 4975 in Patients Undergoing Primary Unilateral Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00683267
- Acronym / sponsor ID
- 114-03P
- Conditions
- Arthroplasty
- Keywords
- THA, Total hip arthroplasty, total hip replacement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment of patients has halted prematurely and will not resume. No future patients will be enrolled or treated.
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Anesiva, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 23 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, 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 4975, highly purified capsaicinStudy treatment, 4975, is instilled directly into surgical site |
| 2 | Placebo comparator | Drug: PlaceboPlacebo is instilled directly into surgical site |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (6 listed)
- 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
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, highly purified capsaicinAlso: 4975, AdleaOne dose administered by direct instillation into the surgical site | Drug | 1 |
| PlaceboOne dose administered by direct instillation into the surgical site | Drug | 2 |
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 endpoints, safety and tolerability of 4975
Time frame: 42 Days
Results and safety
The study was stopped early (reason given: Enrollment of patients has halted prematurely and will not resume. No future patients will be enrolled or treated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2009.
- Anesiva 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, MBA study director
Anesiva, Inc.
William Houghton, MD study director
Anesiva, Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 4975, highly purified capsaicin in people with Arthroplasty, run by Anesiva, Inc. at 10 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 5 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: stopped early, 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 10 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Enrollment of patients has halted prematurely and will not resume. No future patients will be enrolled or treated.). Results are not available in the source record.
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?
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.