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Placebo-Controlled Evaluation of N1539 Following Bunionectomy Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02540265
Recruitment Status : Completed
First Posted : September 3, 2015
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Recro Pharma, Inc.

Tracking Information
First Submitted Date  ICMJE August 31, 2015
First Posted Date  ICMJE September 3, 2015
Results First Submitted Date  ICMJE January 16, 2017
Results First Posted Date  ICMJE June 14, 2017
Last Update Posted Date June 14, 2017
Study Start Date  ICMJE August 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2017)
Number of Subjects With Adverse Events [ Time Frame: Through Day 30 Follow-up ]
Number of subjects reporting treatment emergent adverse events
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2015)
Number of Subjects With Adverse Events [ Time Frame: Up to 7 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2017)
  • Effect Size of N1539 Doses Using the Summed Pain Intensity Difference Over the First 48 Hours (SPID48) [ Time Frame: 48 Hours ]
    Effect size was estimated based on SPID48 derived using 2-hour windowed last observation carried forward (W2LOCF) method and an analysis of covariance (ANCOVA) model that included treatment and baseline PI score.
  • Summed Pain Intensity Difference Over the First 48 Hours (SPID48) [ Time Frame: 48 Hours ]
    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, 2, 4, and 6 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 was better.
  • Summed Pain Intensity Difference (SPID) at Other Intervals [ Time Frame: 48 Hours ]
    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, 2, 4, and 6 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 was better.
  • Number of Subjects With Use of Rescue Medication (Oral Opioids) [ Time Frame: 48 hours ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2015)
  • Summed pain intensity difference over the first 48 hours (SPID48) [ Time Frame: 48 Hours ]
  • Number of Subjects With Use of Rescue Medication (Oral Opioids) [ Time Frame: 48 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Placebo-Controlled Evaluation of N1539 Following Bunionectomy Surgery
Official Title  ICMJE A Phase 2, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety, Efficacy, and Pharmacokinetics of N1539 Following Bunionectomy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain, Post-operative
Intervention  ICMJE
  • Drug: N1539
    Other Name: Intravenous meloxicam
  • Drug: Intravenous Placebo
Study Arms  ICMJE
  • Experimental: N1539 30mg
    N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.
    Intervention: Drug: N1539
  • Experimental: N1539 60mg
    N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.
    Intervention: Drug: N1539
  • Placebo Comparator: IV Placebo
    IV Placebo every 24 hours for up to 3 doses.
    Intervention: Drug: Intravenous Placebo
Publications * 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 Feb 7. pii: rapm-2018-100184. doi: 10.1136/rapm-2018-100184. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 15, 2016)
59
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2015)
60
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02540265
Other Study ID Numbers  ICMJE REC-15-014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Recro Pharma, Inc.
Study Sponsor  ICMJE Recro Pharma, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Recro Pharma, Inc.
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP