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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.

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

Condition or disease Intervention/treatment Phase
Dental Pain Drug: N1539 Drug: placebo Drug: Motrin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Arm Intervention/treatment
Placebo Comparator: placebo Drug: placebo
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

Primary Outcome Measures :
  1. Pain Intensity Difference at End of Study [ Time Frame: 0-24 hours ]

Secondary Outcome Measures :
  1. Onset of action [ Time Frame: 0-1 hour ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00945763

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United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Alkermes, Inc.
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Principal Investigator: Steven Christensen, DDS Jean Brown Research, Salt Lake City, UT 84124
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Alkermes, Inc. Identifier: NCT00945763    
Other Study ID Numbers: N1539-02
First Posted: July 24, 2009    Key Record Dates
Last Update Posted: December 2, 2011
Last Verified: November 2011
Keywords provided by Alkermes, Inc.:
Dental Pain
Additional relevant MeSH terms:
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Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors