Placebo-Controlled Evaluation of N1539 Following Bunionectomy Surgery

Baudax Bio

Status and phase: Completed; Phase 2

Conditions: Pain, Post-operative

Treatments: Drug: Intravenous Placebo; Drug: N1539

Study type: Interventional

Funder types: Industry

Identifiers

NCT02540265

REC-15-014

Details and patient eligibility

About

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

Enrollment: 59 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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59 participants in 3 patient groups, including a placebo group

N1539 30mg

Experimental group

Description:

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

Treatment:

Drug: N1539

N1539 60mg

Experimental group

Description:

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

Treatment:

Drug: N1539

IV Placebo

Placebo Comparator group

Description:

IV Placebo every 24 hours for up to 3 doses.

Treatment:

Drug: Intravenous Placebo