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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.
ClinicalTrials.gov Identifier:
NCT00945763
First received: July 23, 2009
Last updated: November 28, 2011
Last verified: November 2011

July 23, 2009
November 28, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00945763 on ClinicalTrials.gov Archive Site
Onset of action [ Time Frame: 0-1 hour ] [ Designated as safety issue: No ]
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dental Pain
  • Drug: N1539
    30 mg
    Other Name: meloxicam
  • Drug: placebo
    tablets
    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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
230
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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00945763
N1539-02
No
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