PainPhase 3NCT00656578
Efficacy and Safety Study of 4975 to Manage Pain of Bunionectomy
A Phase 3 study testing 4975 in people with Pain, run by Anesiva, Inc. at 6 sites in United States.
Trial summary
The primary purpose of this study is to compare the analgesic efficacy of a single intraoperative administration of 4975 vs. Placebo in the management of acute postoperative pain in patients undergoing bunionectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- 4975
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2008to Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 years and older.
- Planning to undergo unilateral transpositional first metatarsal osteotomy for correction of Hallux Valgus Deformity (referred to as bunionectomy in this protocol).
Who cannot join
- Use of certain medications or having 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.
- Participated in another clinical trial or used an investigational product within 30 days prior to the planned bunionectomy surgery, or is scheduled to receive an investigational product other than 4975 while participating in the study.
- Previously participated in a clinical study with 4975.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Scirex Research Center
Austin, Texas, 78705
Foot and Ankle Institute
Bakersfield, California, 93311
Crossroads Research, Inc.
Owings Mills, Maryland, 21117
Scirex Research Center
Salt Lake City, Utah, 84117
San Antonio Podiatry Associates, PC
San Antonio, Texas, 78229
Hill Country Sports Medicine of Podiatric Surgery
San Marcos, Texas, 78666
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Efficacy and Safety of a Single Intraoperative Administration of 4975 in Patients Undergoing Unilateral Transpositional First Metatarsal Osteotomy for the Correction of Hallux Valgus Deformity
The primary purpose of this study is to compare the analgesic efficacy of a single intraoperative administration of 4975 vs. Placebo in the management of acute postoperative pain in patients undergoing bunionectomy.
Secondary objective of this study is to evaluate the safety and tolerability of a single intraoperative administration of 4975.
Read the detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the US. A dose of 4975 will be evaluated against placebo in patients undergoing bunionectomy. Upon enrollment, patients will be randomized in a 1:1 ratio to receive either 4975 or placebo.
After the surgery, patients will be admitted to the clinical study site, where trained study personnel will monitor them for up to 48 hours. While at the clinical study site, patients will undergo safety and efficacy assessments. After discharge, patients will report pain severity daily through Day 14 via an interactive voice response system (IVRS). Also, safety and patient-reported outcome assessments will be performed at the Day 14 (Week 2) and Day 28 (Week 4) clinic visits.
- Conditions
- Pain
- Being tested
- 4975, Placebo
- Keywords
- Foot, Bunion, Bunionectomy, Hallux Valgus Deformity, Surgery for Transpositional first metatarsal osteotomy - Bunionectomy
- Medical subject headings
- Pain, Bunion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4975Drug
Single dose, solution
PlaceboDrug
Single dose, solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 4975 Receives: Drug: 4975 |
| 2 | Placebo comparator | Drug, Single dose, solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate efficacy of a single intraoperative administration of 4975 in the management of acute postoperative pain in patients undergoing bunionectomy
Measured: Prospective
Secondary outcomes (1)
Evaluate safety and tolerability of a single intraoperative administration of 4975
Measured: Prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anesiva, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656578
- Sponsor's protocol ID
- 114-08P
- Status last verified
- May 2009
- First submitted
- 7 Apr 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 and Safety of a Single Intraoperative Administration of 4975 in Patients Undergoing Unilateral Transpositional First Metatarsal Osteotomy for the Correction of Hallux Valgus Deformity
- ClinicalTrials.gov ID
- NCT00656578
- Acronym / sponsor ID
- 114-08P
- Conditions
- Pain
- Keywords
- Foot, Bunion, Bunionectomy, Hallux Valgus Deformity, Surgery for Transpositional first metatarsal osteotomy - Bunionectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Anesiva, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 11 Apr 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.
The primary purpose of this study is to compare the analgesic efficacy of a single intraoperative administration of 4975 vs. Placebo in the management of acute postoperative pain in patients undergoing bunionectomy.
Secondary objective of this study is to evaluate the safety and tolerability of a single intraoperative administration of 4975.
Detailed description
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in the US. A dose of 4975 will be evaluated against placebo in patients undergoing bunionectomy. Upon enrollment, patients will be randomized in a 1:1 ratio to receive either 4975 or placebo.
After the surgery, patients will be admitted to the clinical study site, where trained study personnel will monitor them for up to 48 hours. While at the clinical study site, patients will undergo safety and efficacy assessments. After discharge, patients will report pain severity daily through Day 14 via an interactive voice response system (IVRS). Also, safety and patient-reported outcome assessments will be performed at the Day 14 (Week 2) and Day 28 (Week 4) clinic visits.
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: 49754975 |
| 2 | Placebo comparator | Drug: PlaceboDrug, Single dose, solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female aged 18 years and older.
- Planning to undergo unilateral transpositional first metatarsal osteotomy for correction of Hallux Valgus Deformity (referred to as bunionectomy in this protocol).
Key exclusion criteria (4 listed)
- Use of certain medications or having 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.
- Participated in another clinical trial or used an investigational product within 30 days prior to the planned bunionectomy surgery, or is scheduled to receive an investigational product other than 4975 while participating in the study.
- Previously participated in a clinical study with 4975.
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 |
|---|---|---|
| 4975Single dose, solution | Drug | 1 |
| PlaceboSingle dose, solution | Drug | 2 |
Primary outcome
Evaluate efficacy of a single intraoperative administration of 4975 in the management of acute postoperative pain in patients undergoing bunionectomy
Time frame: Prospective
1 secondary outcome
Evaluate safety and tolerability of a single intraoperative administration of 4975
Time frame: Prospective
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.
- Anesiva, Inc. Home pageLink provided by the sponsor.
- 4975 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.
The record lists no contact. Use the official record to reach the sponsor.
6 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 in people with Pain, run by Anesiva, Inc. at 6 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 4 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 6 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?
Evaluate efficacy of a single intraoperative administration of 4975 in the management of acute postoperative pain in patients undergoing bunionectomy (time frame: Prospective). 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.