Pain, PostoperativePhase 3NCT00709436
Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery
A Phase 3 study testing PMI-150 (intranasal ketamine) in people with Pain, Postoperative, run by Hospira, now a wholly owned subsidiary of Pfizer at 16 sites in United States.
Trial summary
The purpose of this research study is to evaluate the safety and analgesic efficacy of PMI-150 (intranasal ketamine) compared to placebo in patients with acute post-operative pain following orthopedic trauma, injury, or surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- PMI-150 (intranasal ketamine)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 16 sitesUnited States
- Study dates
- Jun 2008to Aug 2011
- 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
- patient is scheduled for elective orthopedic surgery or procedure
Who cannot join
- patient has received an investigational drug or participated in a clinical trial within 30 days or 5 half-lives (whichever is longer) of entering this study
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Allegehny Pain Management
Altoona, Pennsylvania, 16602
Southeastern Center for Clinical Research
Atlanta, Georgia, 30350
JDP Medical
Aurora, Colorado, 80014
Vertex Clinical Research
Bakersfield, California, CA
Jefferson Clinic
Birmingham, Alabama, 35233
The Ohio State University
Columbus, Ohio, 43210
California Clinical Research
Davis, California, 95616
CORE Orthopedic Medical Center
Encinitas, California, 92024
Shoals Clinical Research
Florence, Alabama, 35630
Comprehensive Pain Specialists
Hendersonville, Tennessee, 37075
Chesapeake Research Group
Pasadena, Maryland, 21122
Arizona Research Center
Phoenix, Arizona, 85023
Jean Brown Research
Salt Lake City, Utah, 84117
Helen Keller Hospital
Sheffield, Alabama, 25660
University Orthopedics
State College, Pennsylvania, 16801
Scott and White Memorial Hospital
Temple, Texas, 76508
About this study
Official title: Randomized, Multiple-center, Double-blind, Placebo-controlled Study of the Safety and Analgesic Efficacy of Repeated Dosing of PMI-150 (Intranasal Ketamine) to Treat Acute Post-operative Pain Following Orthopedic Trauma, Injury, or Surgery.
The purpose of this research study is to evaluate the safety and analgesic efficacy of PMI-150 (intranasal ketamine) compared to placebo in patients with acute post-operative pain following orthopedic trauma, injury, or surgery.
Read the detailed description
Patients will be randomly assigned to PMI-150 (intranasal ketamine) or placebo and will receive repeated doses and be assessed for safety and efficacy.
- Conditions
- Pain, Postoperative
- Being tested
- PMI-150 (intranasal ketamine), Placebo
- Keywords
- orthopedic, ketamine, pain
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMI-150 (intranasal ketamine)Drug
PMI-150 (intranasal ketamine) at time 0 and scheduled times thereafter.
PlaceboDrug
Placebo (intranasal) at time 0 and scheduled times thereafter.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | PMI-150 (intranasal ketamine) at time 0 and specified time points thereafter. Receives: Drug: PMI-150 (intranasal ketamine) |
| 2 | Placebo comparator | Placebo at time 0 and specified time points thereafter. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of pain intensity difference
Measured: 0-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Javelin Pharmaceuticals, Study director, Javelin Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709436
- Sponsor's protocol ID
- KET-017
- Status last verified
- Jan 2012
- First submitted
- 1 Jul 2008
- Last updated
- 11 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multiple-center, Double-blind, Placebo-controlled Study of the Safety and Analgesic Efficacy of Repeated Dosing of PMI-150 (Intranasal Ketamine) to Treat Acute Post-operative Pain Following Orthopedic Trauma, Injury, or Surgery.
- ClinicalTrials.gov ID
- NCT00709436
- Acronym / sponsor ID
- KET-017
- Conditions
- Pain, Postoperative
- Keywords
- orthopedic, ketamine, pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Hospira, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 3 Jul 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 research study is to evaluate the safety and analgesic efficacy of PMI-150 (intranasal ketamine) compared to placebo in patients with acute post-operative pain following orthopedic trauma, injury, or surgery.
Detailed description
Patients will be randomly assigned to PMI-150 (intranasal ketamine) or placebo and will receive repeated doses and be assessed for safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PMI-150 (intranasal ketamine)PMI-150 (intranasal ketamine) at time 0 and specified time points thereafter. |
| 2 | Placebo comparator | Drug: PlaceboPlacebo at time 0 and specified time points thereafter. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient is scheduled for elective orthopedic surgery or procedure
Key exclusion criteria (1 listed)
- patient has received an investigational drug or participated in a clinical trial within 30 days or 5 half-lives (whichever is longer) of entering this study
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 |
|---|---|---|
| PMI-150 (intranasal ketamine)PMI-150 (intranasal ketamine) at time 0 and scheduled times thereafter. | Drug | 1 |
| PlaceboPlacebo (intranasal) at time 0 and scheduled times thereafter. | Drug | 2 |
Primary outcome
Measures of pain intensity difference
Time frame: 0-6 hours
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 11 Jan 2012.
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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.
Javelin Pharmaceuticals study director
Javelin Pharmaceuticals
16 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 PMI-150 (intranasal ketamine) in people with Pain, Postoperative, run by Hospira, now a wholly owned subsidiary of Pfizer at 16 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 1 inclusion and 1 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 11 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
Measures of pain intensity difference (time frame: 0-6 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 11 Jan 2012.