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Single Dose Study of N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery

Primary Purpose

Dental Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
N1539
placebo
N1539
N1539
Motrin
Sponsored by
Alkermes, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Pain focused on measuring Dental Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • surgical extraction of > 2 third molars with at least 1 complete or partial mandibular bony extraction

Exclusion Criteria:

  • allergic response to aspirin, NSAIDs, acetaminophen or hydrocodone
  • use of aspirin or other analgesics within 48 hours prior to surgery
  • current or recent history of drug or alcohol abuse
  • any medication for treatment of chronic pain
  • clinically significant abnormality on screening laboratory test active or recent history of peptic ulcer disease or GI bleeding
  • prior abdominal surgery, except uncomplicated appendectomy
  • any other surgical procedure within 30 days before administration of study drug
  • pregnancy or breastfeeding
  • untreated hypertension; SBP > 140 mmHg or DBP > 95 mmHg

Sites / Locations

  • Jean Brown Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Active Comparator

Arm Label

placebo

N1539 15 mg

N1539 30 mg

N1539 60 mg

Motrin

Arm Description

Outcomes

Primary Outcome Measures

Pain Intensity Difference at End of Study

Secondary Outcome Measures

Onset of action

Full Information

First Posted
July 23, 2009
Last Updated
November 28, 2011
Sponsor
Alkermes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00945763
Brief Title
Single Dose Study of N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery
Official Title
A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Adaptive Design, Single-Dose Study of Intravenous N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alkermes, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the safety and efficacy of single IV doses of N1539 after dental impaction surgery.
Detailed Description
This is a randomized, double-blind, placebo-controlled, single center study in subjects who have undergone third molar extraction surgery. Eligible subjects will have surgical removal of >2 third molars, of which at least 1 must be a complete or partial mandibular impaction. Each subject's study participation will consist of a screening visit (1-21 days prior to surgery), an inpatient evaluation period of 24 hours following dosing, and a follow-up phone call 3-5 days postdose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pain
Keywords
Dental Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Title
N1539 15 mg
Arm Type
Experimental
Arm Title
N1539 30 mg
Arm Type
Experimental
Arm Title
N1539 60 mg
Arm Type
Experimental
Arm Title
Motrin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
N1539
Other Intervention Name(s)
meloxicam
Intervention Description
30 mg
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
sugar pill
Intervention Description
tablets
Intervention Type
Drug
Intervention Name(s)
N1539
Other Intervention Name(s)
meloxicam
Intervention Description
15 mg
Intervention Type
Drug
Intervention Name(s)
N1539
Other Intervention Name(s)
meloxicam
Intervention Description
60 mg
Intervention Type
Drug
Intervention Name(s)
Motrin
Other Intervention Name(s)
ibuprofen
Intervention Description
400 mg
Primary Outcome Measure Information:
Title
Pain Intensity Difference at End of Study
Time Frame
0-24 hours
Secondary Outcome Measure Information:
Title
Onset of action
Time Frame
0-1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: surgical extraction of > 2 third molars with at least 1 complete or partial mandibular bony extraction Exclusion Criteria: allergic response to aspirin, NSAIDs, acetaminophen or hydrocodone use of aspirin or other analgesics within 48 hours prior to surgery current or recent history of drug or alcohol abuse any medication for treatment of chronic pain clinically significant abnormality on screening laboratory test active or recent history of peptic ulcer disease or GI bleeding prior abdominal surgery, except uncomplicated appendectomy any other surgical procedure within 30 days before administration of study drug pregnancy or breastfeeding untreated hypertension; SBP > 140 mmHg or DBP > 95 mmHg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Christensen, DDS
Organizational Affiliation
Jean Brown Research, Salt Lake City, UT 84124
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30737315
Citation
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.
Results Reference
derived
PubMed Identifier
29329493
Citation
Christensen SE, Cooper SA, Mack RJ, McCallum SW, Du W, Freyer A. A Randomized Double-Blind Controlled Trial of Intravenous Meloxicam in the Treatment of Pain Following Dental Impaction Surgery. J Clin Pharmacol. 2018 May;58(5):593-605. doi: 10.1002/jcph.1058. Epub 2018 Jan 12.
Results Reference
derived
Links:
URL
http://www.jeanbrownresearch.com
Description
Study site

Learn more about this trial

Single Dose Study of N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery

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