NCT02678286

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 abdominoplasty surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 14, 2018

Completed
Last Updated

February 14, 2018

Status Verified

January 1, 2018

Enrollment Period

9 months

First QC Date

February 1, 2016

Results QC Date

December 13, 2017

Last Update Submit

January 17, 2018

Conditions

Pain, Post-operative

Keywords

AbdominoplastyPainAnalgesiaN1539Phase 3

Outcome Measures

Primary Outcomes (1)

  • Summed Pain Intensity Difference Over the First 24 Hours (SPID24)

    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.

    24 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

  • +7 more secondary outcomes

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

N1539DRUG
Also known as: Intravenous meloxicam
N1539 30mg
Intravenous PlaceboDRUG
IV Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 elective abdominoplasty surgery without collateral procedures.
  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Lotus Clinical Research, LLC

Pasadena, California, United States

Location

HD Research

Bellaire, Texas, United States

Location

Research Concepts

Bellaire, Texas, 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: 30737315DERIVED

MeSH Terms

Conditions

Pain, PostoperativePainAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Results Point of Contact

Title
Randall Mack
Organization
Recro Pharma
rmack@recropharma.com
484-35-2470

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 9, 2016

Study Start

January 1, 2016

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

February 14, 2018

Results First Posted

February 14, 2018

Record last verified: 2018-01

Locations

US(4)