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

Dental Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00945763
• Other study ID #: N1539-02
• Status: Completed
• Phase: Phase 2
• First received: July 23, 2009
• Last updated: November 28, 2011
• Start date: July 2009
• Est. completion date: November 2009

Study information

• Verified date: November 2011
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Dental Pain
• Tooth, Impacted
• Toothache

Intervention

Drug:
• N1539
30 mg
• placebo
tablets
• N1539
15 mg
• N1539
60 mg
• Motrin
400 mg

Locations

Country	Name	City	State
United States	Jean Brown Research	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity Difference at End of Study		0-24 hours	No
Secondary	Onset of action		0-1 hour	No

External Links

•   Study site