Search / Trial NCT00001724

Local Flurbiprofen to Treat Pain Following Wisdom Tooth Extraction

Launched by NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH (NIDCR) · Nov 3, 1999

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Trial Information

Current as of July 23, 2024

Completed

Keywords

Pain Microencapsulated Drug Nsaid Acute Inflammation Peripheral Administration Dose Response Relative Potency Assay Pharmacokinetics

Description

This study proposes to evaluate the analgesic efficacy, tissue response, and adverse effects of microencapsulated preparations of a nonsteroidal anti-inflammatory drug (NSAID) and a long-acting local anesthetic administered into post-extraction sites prior to pain onset. Subjects (N=84) will have two mandibular impacted third molars removed and be randomly allocated to receive one of six possible treatments placed into the sockets: 0 mg (placebo formulation), 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg flurbiprofen, or 50 mg bupivacaine. Each patient in these six groups (N=12/group) will also rece...

Gender

All

Eligibility criteria

  • Patients of either sex requiring removal of two impacted mandibular third molars (partial bony or soft tissue impaction).
  • 16 years of age of older.
  • Indicates willingness to undergo oral surgery with local anesthesia and intravenous midazolam only.
  • Willing to return for the removal of the remaining maxillary third molars at a second appointment.
  • Patients with a history of allergy to flurbiprofen, aspirin, or any NSAID will be excluded.
  • Those with a history of aspirin or NSAID-induced asthma will be excluded.
  • Females of childbearing potential who are not practicing adequate contraception will be excluded.
  • Pregnant or nursing females will be excluded.
  • Patients with recent history or present signs of renal, hepatic, endocrine, pulmonary, cardiac, gastrointestinal, neurologic, or cerebral function impairment will be excluded.
  • Those with psychiatric disorders will be excluded.
  • Patients who have taken an investigational drug within 30 days of this study will be excluded.
  • Those who have taken another analgesic, steroid, opioid, or NSAID within 24 hours prior to the study will be excluded.
  • Those with an absence of bilateral local anesthesia during surgery as evidenced by anesthesia or paresthesia of the lower lip postoperatively will be excluded.
  • Patients who use drugs which will interact with NSAID such as aspirin, warfarin, probenecid, methotrexate, lithium and diuretics will be excluded.

Attachments

readout_NCT00001724_2024-07-23.pdf

4.5 MB

NCT00001724_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
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1 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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