Acute PainPhase 3NCT00655291
Efficacy of XP20B Following Bunionectomy Surgery
A Phase 3 study testing XP20B in people with Acute Pain, run by Xanodyne Pharmaceuticals at 6 sites in United States.
Trial summary
The purpose of this study is to determine if XP20B is an effective treatment for the relief of pain following bunionectomy surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain
- What is being tested?
- XP20B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2008to Aug 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- having undergone bunionectomy surgery
- having achieved the requisite level of pain
Who cannot join
- pregnant or lactating
- history of substance abuse
- clinically significant condition or lab abnormality
- taken any prohibited medications
- gastrointestinal bleeding or history of
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Investigatve Site
Anaheim, California, 92810
Investigative Site
Austin, Texas, 78705
Investigative Site
Houston, Texas, 78705
Investigative Site
Owings Mills, Maryland, 21117
Investigative Site
Salt Lake City, Utah, 84117
Investigative Site
San Marcos, Texas, 78666
About this study
Official title: Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study of the Analgesic Efficacy of XP20B in Subjects With Pain Following Bunionectomy Surgery
The purpose of this study is to determine if XP20B is an effective treatment for the relief of pain following bunionectomy surgery.
- Conditions
- Acute Pain
- Being tested
- XP20B, Placebo
- Keywords
- pain
- Medical subject headings
- Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XP20BDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Not described Receives: Drug: Placebo |
| B | Experimental | Not described Receives: Drug: XP20B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average pain over a fixed dosing period
Measured: Multiple-day
Secondary outcomes (3)
multiple pain assessments over a fixed dosing period
Measured: Multiple-day
Rescue medication use
Measured: Multiple-day
Safety evaluations
Measured: Multiple-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xanodyne Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Keith Moore, PharmD, Xanodyne Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655291
- Sponsor's protocol ID
- XP20B-301
- Status last verified
- Oct 2008
- First submitted
- 3 Apr 2008
- Last updated
- 8 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study of the Analgesic Efficacy of XP20B in Subjects With Pain Following Bunionectomy Surgery
- ClinicalTrials.gov ID
- NCT00655291
- Acronym / sponsor ID
- XP20B-301
- Conditions
- Acute Pain
- Keywords
- pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Xanodyne PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 9 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 purpose of this study is to determine if XP20B is an effective treatment for the relief of pain following bunionectomy surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: Placebo |
| B | Experimental | Drug: XP20B |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- having undergone bunionectomy surgery
- having achieved the requisite level of pain
Key exclusion criteria (5 listed)
- pregnant or lactating
- history of substance abuse
- clinically significant condition or lab abnormality
- taken any prohibited medications
- gastrointestinal bleeding or history of
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 |
|---|---|---|
| XP20B | Drug | B |
| Placebo | Drug | A |
Primary outcome
Average pain over a fixed dosing period
Time frame: Multiple-day
3 secondary outcomes
multiple pain assessments over a fixed dosing period
Time frame: Multiple-day
Rescue medication use
Time frame: Multiple-day
Safety evaluations
Time frame: Multiple-day
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 8 Oct 2008.
Related trials for Acute Pain
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
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.
Keith Moore, PharmD
Xanodyne Pharmaceuticals
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 XP20B in people with Acute Pain, run by Xanodyne Pharmaceuticals 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 5 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 8 Oct 2008. 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?
Average pain over a fixed dosing period (time frame: Multiple-day). 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 8 Oct 2008.