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
ClinicalTrials.gov Identifier:
NCT00945763
First received: July 23, 2009
Last updated: November 28, 2011
Last verified: November 2011
  Purpose

To evaluate the safety and efficacy of single IV doses of N1539 after dental impaction surgery.


Condition Intervention Phase
Dental Pain
Drug: N1539
Drug: placebo
Drug: Motrin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Alkermes:

Primary Outcome Measures:
  • Pain Intensity Difference at End of Study [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Onset of action [ Time Frame: 0-1 hour ] [ Designated as safety issue: No ]

Enrollment: 230
Study Start Date: July 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: placebo
tablets
Other Name: sugar pill
Experimental: N1539 15 mg Drug: N1539
15 mg
Other Name: meloxicam
Experimental: N1539 30 mg Drug: N1539
30 mg
Other Name: meloxicam
Experimental: N1539 60 mg Drug: N1539
60 mg
Other Name: meloxicam
Active Comparator: Motrin Drug: Motrin
400 mg
Other Name: ibuprofen

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945763

Locations
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Alkermes
Investigators
Principal Investigator: Steven Christensen, DDS Jean Brown Research, Salt Lake City, UT 84124
  More Information

Additional Information:
No publications provided

Responsible Party: Alkermes
ClinicalTrials.gov Identifier: NCT00945763     History of Changes
Other Study ID Numbers: N1539-02
Study First Received: July 23, 2009
Last Updated: November 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Alkermes:
Dental Pain

Additional relevant MeSH terms:
Tooth, Impacted
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Signs and Symptoms
Ibuprofen
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 16, 2014