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
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, see Learn About Clinical Studies.

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 July 31, 2014