BunionectomyPhase 2NCT00293631
Study of Lornoxicam or Ketorolac or Placebo for Post-Operative Pain After Bunionectomy
A Phase 2 study testing Lornoxicam 8 mg, Lornoxicam 16 mg and Ketorolac 30 mg in people with Bunionectomy and Orthopedic Surgery, run by POZEN at 1 site in United States.
Trial summary
To determine whether a single dose of intravenous lornoxicam is superior to intravenous placebo for management of post-operative pain in patients who have surgical removal of a bunion on the lower extremity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bunionectomy, Orthopedic Surgery
- What is being tested?
- Lornoxicam 8 mg, Lornoxicam 16 mg and Ketorolac 30 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Mar 2006
- 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 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- Subjects who are scheduled for a primary unilateral first metatarsal bunionectomy under local anesthetic.
- Subjects have no contraindications to this surgery and have no allergies to the study medications or similar medications.
- Subjects are in generally good health with no uncontrolled chronic illnesses or diseases.
Who cannot join
- Subjects who are pregnant.
- Subjects who have significant obesity.
- Subjects with medically significant heart, liver, kidney, lung or endocrine disease.
- Subjects with active viral disease, i.e. hepatitis, HIV.
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Clinical Research Institute
Anaheim, California, 92801
About this study
Official title: A Randomized, Parallel-Group, Double-Blind, Single-Dose Study Evaluating the Efficacy and Safety of Intravenous Lornoxicam (8 mg and 16 mg) Compared to Intravenous Placebo and Ketorolac 30 mg in Management of Acute Postoperative Pain Following Orthopedic Surgery (Bunionectomy).
To determine whether a single dose of intravenous lornoxicam is superior to intravenous placebo for management of post-operative pain in patients who have surgical removal of a bunion on the lower extremity. One-fourth of patients in this study will receive a single dose of intravenous ketorolac for management of pain and one-fourth of patients in this study will receive a single dose of an intravenous placebo.
- Conditions
- Bunionectomy, Orthopedic Surgery
- Being tested
- Lornoxicam 8 mg, Lornoxicam 16 mg, Ketorolac 30 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lornoxicam 8 mgDrug
Lornoxicam 16 mgDrug
Ketorolac 30 mgDrug
PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The analgesic efficacy (TOTPAR) over 0-12 hours measured on a 100 point Visual Analog Scale (VAS) of a single intravenous dose of lornoxicam (8 mg or 16 mg) compared to placebo in the treatment of post-orthopedic surgery (bunionectomy)
To evaluate the safety and tolerability of lornoxicam administered to subjects with post-bunionectomy surgery pain.
Secondary outcomes (1)
To determine the time to onset of analgesic effect and peak analgesic effect of lornoxicam (8 mg and 16 mg) compared to placebo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2006 (estimated)
- Study startNov 2005
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BunionectomyStudies 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
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- POZEN
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael P. DeMicco, MD, Principal investigator, Advanced Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293631
- Sponsor's protocol ID
- LNP-202
- Status last verified
- Nov 2012
- First submitted
- 15 Feb 2006
- Last updated
- 3 Dec 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-Group, Double-Blind, Single-Dose Study Evaluating the Efficacy and Safety of Intravenous Lornoxicam (8 mg and 16 mg) Compared to Intravenous Placebo and Ketorolac 30 mg in Management of Acute Postoperative Pain Following Orthopedic Surgery (Bunionectomy).
- ClinicalTrials.gov ID
- NCT00293631
- Acronym / sponsor ID
- LNP-202
- Conditions
- Bunionectomy, Orthopedic Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- POZENIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 17 Feb 2006 (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.
To determine whether a single dose of intravenous lornoxicam is superior to intravenous placebo for management of post-operative pain in patients who have surgical removal of a bunion on the lower extremity. One-fourth of patients in this study will receive a single dose of intravenous ketorolac for management of pain and one-fourth of patients in this study will receive a single dose of an intravenous placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects who are scheduled for a primary unilateral first metatarsal bunionectomy under local anesthetic.
- Subjects have no contraindications to this surgery and have no allergies to the study medications or similar medications.
- Subjects are in generally good health with no uncontrolled chronic illnesses or diseases.
Key exclusion criteria (4 listed)
- Subjects who are pregnant.
- Subjects who have significant obesity.
- Subjects with medically significant heart, liver, kidney, lung or endocrine disease.
- Subjects with active viral disease, i.e. hepatitis, HIV.
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 |
|---|---|---|
| Lornoxicam 8 mg | Drug | – |
| Lornoxicam 16 mg | Drug | – |
| Ketorolac 30 mg | Drug | – |
| Placebo | Drug | – |
Primary outcome
The analgesic efficacy (TOTPAR) over 0-12 hours measured on a 100 point Visual Analog Scale (VAS) of a single intravenous dose of lornoxicam (8 mg or 16 mg) compared to placebo in the treatment of post-orthopedic surgery (bunionectomy)
To evaluate the safety and tolerability of lornoxicam administered to subjects with post-bunionectomy surgery pain.
1 secondary outcome
To determine the time to onset of analgesic effect and peak analgesic effect of lornoxicam (8 mg and 16 mg) compared to placebo.
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 3 Dec 2012.
Related trials for Bunionectomy
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A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
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Phase 3 Bunionectomy Study
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A Clinical Trial of GRT7040 in Adults With Acute Pain Following Bunionectomy
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A Study of TLC590 for Postsurgical Pain Following Bunionectomy
Postoperative Pain
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.
Michael P. DeMicco, MD principal investigator
Advanced Clinical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lornoxicam 8 mg, Lornoxicam 16 mg and Ketorolac 30 mg in people with Bunionectomy and Orthopedic Surgery, run by POZEN at 1 site 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 3 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 3 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 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?
The analgesic efficacy (TOTPAR) over 0-12 hours measured on a 100 point Visual Analog Scale (VAS) of a single intravenous dose of lornoxicam (8 mg or 16 mg) compared to placebo in the treatment of post-orthopedic surgery (bunionectomy). The study lists 2 primary outcomes in all. 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 3 Dec 2012.