Placebo-Controlled Evaluation of N1539 Following Bunionectomy Surgery

NCT ID: NCT02540265

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2015-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

N1539 30mg

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

Group Type: EXPERIMENTAL

N1539

Intervention Type: DRUG

N1539 60mg

N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.

Group Type: EXPERIMENTAL

N1539

Intervention Type: DRUG

IV Placebo

IV Placebo every 24 hours for up to 3 doses.

Group Type: PLACEBO_COMPARATOR

Intravenous Placebo

Intervention Type: DRUG

Interventions

N1539

Intervention Type: DRUG

Intravenous Placebo

Intervention Type: DRUG

Other Intervention Names

Intravenous meloxicam

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baudax Bio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chesapeake Research Group, LLC

Pasadena, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30737315 (View on PubMed)

Other Identifiers

REC-15-014

Identifier Type: -

Identifier Source: org_study_id