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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00945763
Other study ID # N1539-02
Secondary ID
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


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
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