Pain, Post-operativePhase 3NCT02675907
Evaluation of N1539 Following Bunionectomy Surgery
A Phase 3 study testing N1539 in people with Pain, Post-operative, run by Baudax Bio at 4 sites in United States.
Trial summary
The primary objective of this study is to evaluate the analgesic efficacy of N1539 in subjects with acute moderate to severe pain following unilateral bunionectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Post-operative
- What is being tested?
- N1539
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2016to Jul 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily provide written informed consent.
- Male or female between 18 and 75 years of age, inclusive.
- Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair
- Be American Society of Anesthesiology (ASA) physical class 1 or 2.
- Female subject are eligible only if all the following apply:
- Not pregnant;
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- Not lactating;
- Not planning to become pregnant during the study;
- Commit to the use of an acceptable form of birth control for the duration of the study.
- Have a body mass index ≤35 kg/m2
- Be able to understand the study procedures, comply with all study procedures, and agree to participate in the study program.
Who cannot join
- Have a known allergy to meloxicam or any excipient of N1539, D5W, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs) or to any peri- or postoperative medications used in this study.
- Have a clinically significant abnormal clinical laboratory test value.
- Have history of or positive test results for HIV, or hepatitis B or C.
- Have a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study.
- Have a history of myocardial infarction or coronary artery bypass graft surgery within the preceding 12 months
- Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants.
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- Have active or recent (within 6 months) gastrointestinal ulceration or bleeding.
- Have a known bleeding disorder or be taking agents affecting coagulation
- Have another painful physical condition that may confound the assessments of post operative pain.
- Have evidence of a clinically significant 12 lead ECG abnormality.
- Have a history of alcohol abuse (regularly drinks > 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) within the past 5 years or a history of prescription/illicit drug abuse.
- Have positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.
- Have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months of surgery.
- Use concurrent therapy that could interfere with the evaluation of efficacy or safety, such as any drugs which in the investigator's opinion may exert significant analgesic properties or act synergistically with N1539.
- Unable to discontinue medications, that have not been at a stable dose for at least 14 days prior to the scheduled bunionectomy procedure, within 5 half lives of the specific prior medication (or, if half life is not known, within 48 hours) before dosing with study medication.
- Have utilized corticosteroids, either systemically or by intra-articular injection, within 6 weeks prior to the surgical procedure.
- Have received any investigational product within 30 days before dosing with study medication.
- Be receiving warfarin, lithium, or a combination of furosemide with either an angiotensin converting enzyme inhibitor or an angiotensin receptor blocker
- Be currently receiving treatment with oral meloxicam (Mobic®) within 7 days prior to surgery
- Have previously received N1539 in clinical trials, or had major surgery in the last 3 months that would interfere with study outcomes or increase the risk of study participation.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Trovare Clinical Research
Bakersfield, California
Lotus Clinical Research
Pasadena, California
Chesapeake Research Group
Pasadena, Maryland
Endeavor Clinical Trials
San Antonio, Texas
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Efficacy and Safety of N1539 Following Bunionectomy
The primary objective of this study is to evaluate the analgesic efficacy of N1539 in subjects with acute moderate to severe pain following unilateral bunionectomy.
- Conditions
- Pain, Post-operative
- Being tested
- N1539, Intravenous Placebo
- Keywords
- Bunion, Bunionectomy, Pain, Analgesia, N1539, Phase 3
- Medical subject headings
- Pain, Postoperative, Bunion, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N1539Drug
Also called Intravenous meloxicam
Intravenous PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| N1539 30mg | Experimental | N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses. Receives: Drug: N1539 |
| IV Placebo | Placebo comparator | IV Placebo every 24 hours for up to 3 doses. Receives: Drug: Intravenous Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summed Pain Intensity Difference Over the First 48 Hours (SPID48)
Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better.
Measured: 48 Hours
Secondary outcomes (12)
Summed Pain Intensity Difference (SPID) at Other Intervals
Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better.
Measured: 48 Hours
Time to First Dose of Rescue Analgesia
Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request. Time to first rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia.
Measured: 48 Hours
Number of Subjects Utilizing Rescue Analgesia
Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request.
Measured: 48 Hours
Number of Doses of Rescue Analgesia Utilized Per Subject
Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request.
Measured: 48 Hours
Time to Perceptible Pain Relief (TTPPR)
Time to perceptible and meaningful pain relief was measured using the double stopwatch method. For each randomized subject, two stopwatches were started immediately after administration of the first study dose (Hour 0). The subject was to stop the first watch when they first perceived pain relief to occur (time to perceptible relief). Once the first watch was stopped, the second stopwatch was given to the subject with the instructions to stop the watch when they first experienced meaningful pain relief (time to meaningful relief).
Measured: 12 Hours
Time to Meaningful Pain Relief (TTMPR)
Time to perceptible and meaningful pain relief was measured using the double stopwatch method. For each randomized subject, two stopwatches were started immediately after administration of the first study dose (Hour 0). The subject was to stop the first watch when they first perceived pain relief to occur (time to perceptible relief). Once the first watch was stopped, the second stopwatch was given to the subject with the instructions to stop the watch when they first experienced meaningful pain relief (time to meaningful relief).
Measured: 12 Hours
Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 6
Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 6 = 100 * SPID6 / (BaselinePI * 6 * 60), and SPID6 < 0 as an indication for improvement.
Measured: 6 Hours
Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 24
Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 24 = 100 * SPID24 / (BaselinePI * 24 * 60), and SPID24 < 0 as an indication for improvement.
Measured: 24 Hours
Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 6
Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 6 = 100 * SPID6 / (BaselinePI * 6 * 60), and SPID6 < 0 as an indication for improvement.
Measured: 6 Hours
Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 24
Percent improvement in pain is the cumulative pain intensity percent reduction from baseline over the defined interval (6 or 24 hours), calculated as SPID for the defined interval (SPID6 or SPID24) divided by the baseline pain intensity (BaselinePI) extrapolated across that interval. Example: % Improvement through Hour 24 = 100 * SPID24 / (BaselinePI * 24 * 60), and SPID24 < 0 as an indication for improvement.
Measured: 24 Hours
Patient Global Assessment (PGA) of Pain Control at Hour 24
PGA of pain control was evaluated at Hour 24 and Hour 48 with subject reported degree of pain control over the preceding interval according to a 5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent.
Measured: 24 Hours
Patient Global Assessment (PGA) of Pain Control at Hour 48
PGA of pain control was evaluated at Hour 24 and Hour 48 with subject reported degree of pain control over the preceding interval according to a 5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent.
Measured: 48 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, Post-operativeStudies 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
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baudax Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675907
- Sponsor's protocol ID
- REC-15-016
- Status last verified
- Oct 2017
- First submitted
- 1 Feb 2016
- Last updated
- 17 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Viscusi ER, Gan TJ, Bergese S, Singla N, Mack RJ, McCallum SW, Du W, Hobson S. Intravenous meloxicam for the treatment of moderate to severe acute pain: a pooled analysis of safety and opioid-reducing effects. Reg Anesth Pain Med. 2019 Mar;44(3):360-368. doi: 10.1136/rapm-2018-100184. Epub 2019 Feb 7.
PubMed 30737315
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Efficacy and Safety of N1539 Following Bunionectomy
- ClinicalTrials.gov ID
- NCT02675907
- Acronym / sponsor ID
- REC-15-016
- Conditions
- Pain, Post-operative
- Keywords
- Bunion, Bunionectomy, Pain, Analgesia, N1539, Phase 3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Baudax BioIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Posted 29 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the analgesic efficacy of N1539 in subjects with acute moderate to severe pain following unilateral bunionectomy.
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 |
|---|---|---|
| N1539 30mg | Experimental | Drug: N1539N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses. |
| IV Placebo | Placebo comparator | Drug: Intravenous PlaceboIV Placebo every 24 hours for up to 3 doses. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Voluntarily provide written informed consent.
- Male or female between 18 and 75 years of age, inclusive.
- Be scheduled to undergo a primary unilateral first metatarsal bunionectomy repair
- Be American Society of Anesthesiology (ASA) physical class 1 or 2.
- Female subject are eligible only if all the following apply:
Key exclusion criteria (20 listed)
- Have a known allergy to meloxicam or any excipient of N1539, D5W, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs) or to any peri- or postoperative medications used in this study.
- Have a clinically significant abnormal clinical laboratory test value.
- Have history of or positive test results for HIV, or hepatitis B or C.
- Have a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study.
- Have a history of myocardial infarction or coronary artery bypass graft surgery within the preceding 12 months
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 |
|---|---|---|
| N1539Also: Intravenous meloxicam | Drug | N1539 30mg |
| Intravenous Placebo | Drug | IV Placebo |
Primary outcome
Summed Pain Intensity Difference Over the First 48 Hours (SPID48)
Time frame: 48 Hours
Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better.
12 secondary outcomes
Summed Pain Intensity Difference (SPID) at Other Intervals
Time frame: 48 Hours
Time to First Dose of Rescue Analgesia
Time frame: 48 Hours
Number of Subjects Utilizing Rescue Analgesia
Time frame: 48 Hours
Number of Doses of Rescue Analgesia Utilized Per Subject
Time frame: 48 Hours
Time to Perceptible Pain Relief (TTPPR)
Time frame: 12 Hours
Time to Meaningful Pain Relief (TTMPR)
Time frame: 12 Hours
Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 6
Time frame: 6 Hours
Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 24
Time frame: 24 Hours
Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 6
Time frame: 6 Hours
Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 24
Time frame: 24 Hours
Patient Global Assessment (PGA) of Pain Control at Hour 24
Time frame: 24 Hours
Patient Global Assessment (PGA) of Pain Control at Hour 48
Time frame: 48 Hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30737315Viscusi ER, Gan TJ, Bergese S, Singla N, Mack RJ, McCallum SW, Du W, Hobson S. Intravenous meloxicam for the treatment of moderate to severe acute pain: a pooled analysis of safety and opioid-reducing effects. Reg Anesth Pain Med. 2019 Mar;44(3):360-368. doi: 10.1136/rapm-2018-100184. Epub 2019 Feb 7.
- Individual participant dataSharing planned: Undecided
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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.
4 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 N1539 in people with Pain, Post-operative, run by Baudax Bio at 4 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 11 inclusion and 20 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 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 29 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Summed Pain Intensity Difference Over the First 48 Hours (SPID48) (time frame: 48 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02675907, which also lists 1 linked publication.
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 17 Nov 2017.