Clinical trial NCT02675907: Evaluation of N1539 Following Bunionectomy Surgery
Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Efficacy and Safety of N1539 Following Bunionectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Post-operative
Keywords: Bunion
Bunionectomy
Pain
Analgesia
N1539
Phase 3
Lead sponsor: Baudax Bio
Sponsor class: INDUSTRY
First posted: 2016-02-05
Enrollment: 201
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 analgesic efficacy 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.
* 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 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.
* 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.

Primary outcomes:
measure: Summed Pain Intensity Difference Over the First 48 Hours (SPID48)
timeFrame: 48 Hours
Secondary outcomes:
measure: Summed Pain Intensity Difference (SPID) at Other Intervals
timeFrame: 48 Hours
measure: Time to First Dose of Rescue Analgesia
timeFrame: 48 Hours
measure: Number of Subjects Utilizing Rescue Analgesia
timeFrame: 48 Hours
measure: Number of Doses of Rescue Analgesia Utilized Per Subject
timeFrame: 48 Hours
measure: Time to Perceptible Pain Relief (TTPPR)
timeFrame: 12 Hours
measure: Time to Meaningful Pain Relief (TTMPR)
timeFrame: 12 Hours
measure: Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 6
timeFrame: 6 Hours
measure: Subjects With ≥ 30% Improvement in Pain From Baseline to Hour 24
timeFrame: 24 Hours
measure: Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 6
timeFrame: 6 Hours
measure: Subjects With ≥ 50% Improvement in Pain From Baseline to Hour 24
timeFrame: 24 Hours
measure: Patient Global Assessment (PGA) of Pain Control at Hour 24
timeFrame: 24 Hours
measure: Patient Global Assessment (PGA) of Pain Control at Hour 48
timeFrame: 48 Hours
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Trovare Clinical Research
state: California
city: Pasadena
country: United States
facility: Lotus Clinical Research
state: California
city: Pasadena
country: United States
facility: Chesapeake Research Group
state: Maryland
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
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.