Single Dose Study of N1539 in the Treatment of Pain Secondary to Dental Impaction 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. Identifier: NCT00945763
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : December 2, 2011
Information provided by (Responsible Party):
Alkermes, Inc.

July 23, 2009
July 24, 2009
December 2, 2011
July 2009
November 2009   (Final data collection date for primary outcome measure)
Pain Intensity Difference at End of Study [ Time Frame: 0-24 hours ]
Same as current
Complete list of historical versions of study NCT00945763 on Archive Site
Onset of action [ Time Frame: 0-1 hour ]
Same as current
Not Provided
Not Provided
Single Dose Study of N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery
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
To evaluate the safety and efficacy of single IV doses of N1539 after dental impaction surgery.
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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dental Pain
  • Drug: N1539
    30 mg
    Other Name: meloxicam
  • Drug: placebo
    Other Name: sugar pill
  • Drug: N1539
    15 mg
    Other Name: meloxicam
  • Drug: N1539
    60 mg
    Other Name: meloxicam
  • Drug: Motrin
    400 mg
    Other Name: ibuprofen
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Experimental: N1539 15 mg
    Intervention: Drug: N1539
  • Experimental: N1539 30 mg
    Intervention: Drug: N1539
  • Experimental: N1539 60 mg
    Intervention: Drug: N1539
  • Active Comparator: Motrin
    Intervention: Drug: Motrin
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 Jan 12. doi: 10.1002/jcph.1058. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2009
November 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Alkermes, Inc.
Alkermes, Inc.
Not Provided
Principal Investigator: Steven Christensen, DDS Jean Brown Research, Salt Lake City, UT 84124
Alkermes, Inc.
November 2011

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