Single Dose Study of N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery
Information source: Elan Drug Delivery Inc
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dental Pain
Intervention: N1539 (Drug); placebo (Drug); N1539 (Drug); N1539 (Drug); ibuprofen (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Elan Drug Delivery Inc Official(s) and/or principal investigator(s):
Steven Christensen, DDS, Principal Investigator, Affiliation: Jean Brown Research, Salt Lake City, UT 84124
Overall contact:
Staci Gola, RN, BSN, Phone: 801-261-2000, Ext: 329, Email: sgola@jeanbrownresearch.com
Summary
To evaluate the safety and efficacy of single IV doses of N1539 after dental impaction
surgery.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Pain Intensity Difference at End of Study
Secondary outcome: Onset of action
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Staci Gola, RN, BSN, Phone: 801-261-2000, Ext: 329, Email: sgola@jeanbrownresearch.com
Jean Brown Research, Salt Lake City, Utah 84124, United States; Recruiting
Patrick Brain, DDS, Sub-Investigator
Additional Information
Study site
Starting date: July 2009
Ending date: November 2009
Last updated: July 31, 2009
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