Single Dose Study of N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery - Full Text View

Sponsor:	Elan Drug Delivery Inc
Information provided by:	Elan Drug Delivery Inc
ClinicalTrials.gov Identifier:	NCT00945763

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: ibuprofen	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Surgery

Drug Information available for: Ibuprofen Meloxicam

U.S. FDA Resources

Further study details as provided by Elan Drug Delivery Inc:

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 ]

Estimated 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: Placebo Comparator	Drug: placebo tablets
N1539 15 mg: Experimental	Drug: N1539 15 mg
N1539 30 mg: Experimental	Drug: N1539 30 mg
N1539 60 mg: Experimental	Drug: N1539 60 mg
Motrin: Active Comparator	Drug: ibuprofen 400 mg

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

Elan Drug Delivery Inc

Investigators

Principal Investigator:

Steven Christensen, DDS

Jean Brown Research, Salt Lake City, UT 84124

More Information

Additional Information:

Study site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Elan Drug Delivery Inc ( Sharon Hamm, Pharm D )
Study ID Numbers:	N1539-02
Study First Received:	July 23, 2009
Last Updated:	November 16, 2009
ClinicalTrials.gov Identifier:	NCT00945763 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Elan Drug Delivery Inc:

Dental Pain

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Tooth Diseases
Ibuprofen
Molecular Mechanisms of Pharmacological Action
Facial Pain
Toothache
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Meloxicam
Enzyme Inhibitors
Pain
Pharmacologic Actions

Signs and Symptoms
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Stomatognathic Diseases
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Tooth, Impacted

ClinicalTrials.gov processed this record on February 08, 2010