Evaluation of N1539 Following Bunionectomy Surgery

NCT02675907 | Completed Phase 3 Results

• 1 other identifier: REC-15-016
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 4

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.

Conditions

Pain, Post-operative

Keywords

Bunion; Bunionectomy; Pain; Analgesia; N1539; Phase 3

Outcome Measures

Primary Outcomes (1)

• 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.

  48 Hours

Secondary Outcomes (12)

• Summed Pain Intensity Difference (SPID) at Other Intervals

  48 Hours

• Time to First Dose of Rescue Analgesia

  48 Hours

• Number of Subjects Utilizing Rescue Analgesia

  48 Hours

• Number of Doses of Rescue Analgesia Utilized Per Subject

  48 Hours

• Time to Perceptible Pain Relief (TTPPR)

  12 Hours

Study Arms (2)

N1539 30mg

EXPERIMENTAL

N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.

Drug: N1539

IV Placebo

PLACEBO COMPARATOR

IV Placebo every 24 hours for up to 3 doses.

Drug: Intravenous Placebo

Interventions

N1539 DRUG

Also known as: Intravenous meloxicam

N1539 30mg

Intravenous Placebo DRUG

IV Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baudax Bio: lead

Study Sites (4)

Trovare Clinical Research

Bakersfield, California, United States

Location

Lotus Clinical Research

Pasadena, California, United States

Location

Chesapeake Research Group

Pasadena, Maryland, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, United States

Location

Related Publications (1)

• 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.

  PMID: 30737315 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Bunion; Pain; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Randall Mack
• Organization: Recro Pharma, Inc.

rmack@recropharma.com

484-395-2470

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: February 5, 2016
• Study Start: January 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: November 17, 2017
• Results First Posted: September 29, 2017

Record last verified: 2017-10

Locations

US (4)