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

NCT ID: NCT00945763

Last Updated: 2011-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Dental Pain

Keywords

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Dental Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

tablets

N1539 15 mg

Group Type EXPERIMENTAL

N1539

Intervention Type DRUG

15 mg

N1539 30 mg

Group Type EXPERIMENTAL

N1539

Intervention Type DRUG

30 mg

N1539 60 mg

Group Type EXPERIMENTAL

N1539

Intervention Type DRUG

60 mg

Motrin

Group Type ACTIVE_COMPARATOR

Motrin

Intervention Type DRUG

400 mg

Interventions

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N1539

30 mg

Intervention Type DRUG

placebo

tablets

Intervention Type DRUG

N1539

15 mg

Intervention Type DRUG

N1539

60 mg

Intervention Type DRUG

Motrin

400 mg

Intervention Type DRUG

Other Intervention Names

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meloxicam sugar pill meloxicam meloxicam ibuprofen

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alkermes, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Christensen, DDS

Role: PRINCIPAL_INVESTIGATOR

Jean Brown Research, Salt Lake City, UT 84124

Locations

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Jean Brown Research

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Viscusi ER, Gan TJ, Bergese S, Singla N, Mack RJ, McCallum SW, Du W, Hobson S. Intravenous meloxicam for the treatment of moderate to severe acute pain: a pooled analysis of safety and opioid-reducing effects. Reg Anesth Pain Med. 2019 Mar;44(3):360-368. doi: 10.1136/rapm-2018-100184. Epub 2019 Feb 7.

Reference Type DERIVED
PMID: 30737315 (View on PubMed)

Christensen SE, Cooper SA, Mack RJ, McCallum SW, Du W, Freyer A. A Randomized Double-Blind Controlled Trial of Intravenous Meloxicam in the Treatment of Pain Following Dental Impaction Surgery. J Clin Pharmacol. 2018 May;58(5):593-605. doi: 10.1002/jcph.1058. Epub 2018 Jan 12.

Reference Type DERIVED
PMID: 29329493 (View on PubMed)

Related Links

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http://www.jeanbrownresearch.com

Study site

Other Identifiers

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N1539-02

Identifier Type: -

Identifier Source: org_study_id