- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02540265
Placebo-Controlled Evaluation of N1539 Following Bunionectomy Surgery
May 16, 2017 updated by: Baudax Bio
A Phase 2, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety, Efficacy, and Pharmacokinetics of N1539 Following Bunionectomy
The primary objective of this study is to evaluate the safety of N1539 in subjects with acute moderate to severe pain following unilateral bunionectomy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Pasadena, Maryland, United States
- Chesapeake Research Group, Llc
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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;
- 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 through Day 30.
- 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.
Exclusion Criteria:
- 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 migraine or frequent headaches, seizures, or are currently taking anticonvulsants.
- Have another painful physical condition that may confound the assessments of post operative pain.
- Have a history of syncope or other syncopal attacks.
- 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) or 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.
- 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.
- Have utilized corticosteroids, either systemically, inhalational either intranasally or oral, or by intra-articular injection, within 14 days prior to the study.
- 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®)
- Have previously received N1539 in clinical trials, or had bunionectomy in the last 3 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: N1539 30mg
N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.
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Other Names:
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EXPERIMENTAL: N1539 60mg
N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.
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Other Names:
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PLACEBO_COMPARATOR: IV Placebo
IV Placebo every 24 hours for up to 3 doses.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects With Adverse Events
Time Frame: Through Day 30 Follow-up
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Number of subjects reporting treatment emergent adverse events
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Through Day 30 Follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect Size of N1539 Doses Using the Summed Pain Intensity Difference Over the First 48 Hours (SPID48)
Time Frame: 48 Hours
|
Effect size was estimated based on SPID48 derived using 2-hour windowed last observation carried forward (W2LOCF) method and an analysis of covariance (ANCOVA) model that included treatment and baseline PI score.
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48 Hours
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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, 2, 4, and 6 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 was better.
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48 Hours
|
Summed Pain Intensity Difference (SPID) at Other Intervals
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, 2, 4, and 6 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 was better.
|
48 Hours
|
Number of Subjects With Use of Rescue Medication (Oral Opioids)
Time Frame: 48 hours
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48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (ACTUAL)
November 1, 2015
Study Completion (ACTUAL)
November 1, 2015
Study Registration Dates
First Submitted
August 31, 2015
First Submitted That Met QC Criteria
September 1, 2015
First Posted (ESTIMATE)
September 3, 2015
Study Record Updates
Last Update Posted (ACTUAL)
June 14, 2017
Last Update Submitted That Met QC Criteria
May 16, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Meloxicam
Other Study ID Numbers
- REC-15-014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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