Clinical trial NCT02540265: Placebo-Controlled Evaluation of N1539 Following Bunionectomy Surgery
Official title: A Phase 2, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety, Efficacy, and Pharmacokinetics of N1539 Following Bunionectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain, Post-operative
Keywords: Bunion
Bunionectomy
Pain
Analgesia
N1539
Lead sponsor: Baudax Bio
Sponsor class: INDUSTRY
First posted: 2015-09-03
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the safety of N1539 in subjects with acute moderate to severe pain following unilateral bunionectomy.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects With Adverse Events
timeFrame: Through Day 30 Follow-up
Secondary outcomes:
measure: Effect Size of N1539 Doses Using the Summed Pain Intensity Difference Over the First 48 Hours (SPID48)
timeFrame: 48 Hours
measure: Summed Pain Intensity Difference Over the First 48 Hours (SPID48)
timeFrame: 48 Hours
measure: Summed Pain Intensity Difference (SPID) at Other Intervals
timeFrame: 48 Hours
measure: Number of Subjects With Use of Rescue Medication (Oral Opioids)
timeFrame: 48 hours
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Chesapeake Research Group, LLC
state: Maryland
Study officials:
References:
citation: 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.