NCT01084161

Brief Summary

To determine the analgesic efficacy, duration of effect, and safety of single doses of N1539 in subjects undergoing open abdominal hysterectomy

Trial Health

90
On Track

Trial Health Score

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

Enrollment
486

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2010

Shorter than P25 for phase_2

Geographic Reach
3 countries

12 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

March 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 10, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

December 2, 2011

Status Verified

November 1, 2011

Enrollment Period

10 months

First QC Date

March 5, 2010

Last Update Submit

November 28, 2011

Conditions

Hysterectomy

Outcome Measures

Primary Outcomes (1)

  • To determine the analgesic efficacy, duration of effect and safety of single doses of IV N1539 as measured by the SPID (summary of pain intensity) and TOPAR (summary of the time-weighted pain relief scores) from 0-24 hours.

    Additionally, to determine the efficacy seen within the first hour after study drug administration, as measured by the SPID 0-60 minutes post-dose.

    at 60 minutes post dose and at 24 hours

Secondary Outcomes (1)

  • To assess the safety and tolerability of IV N1539 by laboratory data, vital signs, wound site evaluation and Adverse Events

    5-7 days post initial dosing

Study Arms (7)

N1539 5 mg

EXPERIMENTAL
Drug: N1539

N1539 7.5 mg

EXPERIMENTAL
Drug: N1539

N1539 15 mg

EXPERIMENTAL
Drug: N1539

N1539 30 mg

EXPERIMENTAL
Drug: N1539

N1539 60 mg

EXPERIMENTAL
Drug: N1539

Placebo

PLACEBO COMPARATOR
Drug: placebo

morphine

ACTIVE COMPARATOR
Drug: Morphine

Interventions

N1539DRUG

5 mg IV once per day

N1539 5 mg
placeboDRUG

IV placebo once per day

Placebo
MorphineDRUG

morphine 10-15 mg IV once per day

morphine

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • moderate to severe pain with VAS of \>/= 45 mm
  • undergo open abdominal hysterectomy
  • ASA I or II
  • signed ICF
  • BMI \>18.5 and \< 31.5 kg/m\^2

You may not qualify if:

  • suspected metastatic cervical or endometrial cancer
  • prior abdominal surgery with postoperative complications
  • active pancreatitis, obstruction of biliary tree or total bilirubin\> 2.5 mg/dL
  • active GI bleeding, or peptic ulcer disease
  • unstable medical condition
  • HbA1c \>9.5 or uncontrolled diabetes
  • SBP \>150 mmHg or DBP \> 95 mmHg
  • personal or familial contraindication to undergoing general anesthesia
  • Antihypertensive agents or diabetic regimen that is not stable (4 weeks prior to surgery)
  • taking CNS agents for pain
  • acetaminophen or NSAIDs not discontinued for at least 5 half-lives prior to planned surgery
  • currently taking an opioid or has taken an opioid chronically for pain in past 2 years
  • corticosteroid or systemic corticosteroids within 6 weeks of planned surgery
  • has a known bleeding disorder or taking agents affecting coagulation
  • history of intolerance or allergic reactions to NSAIDs, COX-2 inhibitors, aspirin and other salicylates
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Tbilisi, 0159, Georgia

Location

Unknown Facility

Tbilisi, 0186, Georgia

Location

Unknown Facility

Bialystok, 15-276, Poland

Location

Unknown Facility

Gdansk, 80-402, Poland

Location

Unknown Facility

Lodz, 94-029, Poland

Location

Unknown Facility

Lublin, 20-081, Poland

Location

Unknown Facility

Poznan, 60-535, Poland

Location

Unknown Facility

Ruda Śląska, 41-703, Poland

Location

Unknown Facility

Szczecin, 70-111, Poland

Location

Unknown Facility

Belgrade, 11000, Serbia

Location

Unknown Facility

Kragujevac, 34000, Serbia

Location

Unknown Facility

Novi Sad, 21000, Serbia

Location

Related Publications (2)

  • Rechberger T, Mack RJ, McCallum SW, Du W, Freyer A. Analgesic Efficacy and Safety of Intravenous Meloxicam in Subjects With Moderate-to-Severe Pain After Open Abdominal Hysterectomy: A Phase 2 Randomized Clinical Trial. Anesth Analg. 2019 Jun;128(6):1309-1318. doi: 10.1213/ANE.0000000000003920.

    PMID: 31094806DERIVED

  • 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

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2010

First Posted

March 10, 2010

Study Start

March 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

December 2, 2011

Record last verified: 2011-11

Locations

SE(3)PL(7)GE(2)