Placebo-Controlled Evaluation of N1539 Following Bunionectomy Surgery

NCT02540265 | Completed Phase 2 Results

• 1 other identifier: REC-15-014
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Post-operative

Keywords

Bunion; Bunionectomy; Pain; Analgesia; N1539

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Adverse Events

  Number of subjects reporting treatment emergent adverse events

  Through Day 30 Follow-up

Secondary Outcomes (4)

• Effect Size of N1539 Doses Using the Summed Pain Intensity Difference Over the First 48 Hours (SPID48)

  48 Hours

• Summed Pain Intensity Difference Over the First 48 Hours (SPID48)

  48 Hours

• Summed Pain Intensity Difference (SPID) at Other Intervals

  48 Hours

• Number of Subjects With Use of Rescue Medication (Oral Opioids)

  48 hours

Study Arms (3)

N1539 30mg

EXPERIMENTAL

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

Drug: N1539

N1539 60mg

EXPERIMENTAL

N1539 (Intravenous meloxicam) 60mg 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; N1539 60mg

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 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.

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 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.

Sponsors & Collaborators

• Baudax Bio: lead

Study Sites (1)

Chesapeake Research Group, LLC

Pasadena, Maryland, 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 2
• 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: August 31, 2015
• First Posted: September 3, 2015
• Study Start: August 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-05

Locations

US (1)