Clinical Trials Logo
  1. Home
  2. Dental Pain
  3. NCT00945763

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 Summary

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

Clinical Trial 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. ;

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

Clinical Trial Details
NCT number NCT00945763
Study type Interventional
Source Alkermes, Inc.
Contact
Status Completed
Phase Phase 2
Start date July 2009
Completion date November 2009
View Details
See also
  Status Clinical Trial Phase
Completed NCT00954356 - Safety and Efficacy Study of XPF-001 to Treat Pain Following Wisdom Tooth Extraction Phase 2
Completed NCT00985439 - Study of Diclofenac Capsules to Treat Dental Pain Phase 2
Completed NCT00943098 - Evaluation of the Efficacy and Safety of Diclofenac HPBCD 75mg/ml in Treatment of Pain Following Dental Surgery Phase 3
Completed NCT00942448 - Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery Phase 3
Completed NCT02966067 - A Split Mouth Trial to Compare Microneedles vs. Standard Needles in Dental Anaesthetic Delivery N/A
Completed NCT01960114 - Study of Long-Acting Acetaminophen in Postoperative Dental Pain Phase 2
Completed NCT01229228 - Study of Naproxen Capsules to Treat Dental Pain Phase 2
Completed NCT01177423 - Efficiency Evaluation of Intradiploic Intra-osseus Anesthesia Versus Inferior Alveolar Nerve Block N/A
Completed NCT03328208 - Nonpharmacologic Reduction of Periprocedural Distress and Drug Use N/A
Completed NCT05236101 - Validation of Child Drawing Hospital Scale (CD: H) and the Place of the Drawing in the Evaluation of Dental Anxiety N/A
Completed NCT00542035 - A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction Phase 2
Completed NCT04231955 - Comparison of Different Pain Rating Scales in Patients With Symptomatic Teeth N/A
Completed NCT02096926 - Methodological Validation of Ibuprofen Verses Placebo for Post Operative Pain After Third Molar Extraction Surgery Phase 4
Completed NCT05369936 - Pain Perception: on Relationships Between Dental Anxiety and Olfaction N/A
Recruiting NCT05351099 - Dental Block for Pain Relief in ED Dental Pain Patients
Not yet recruiting NCT06269406 - A Combination of Ibuprofen With Curcumin Covered With Liquorice Root Supplementation in the Management of Postoperative Dental Pain in Adults N/A
Recruiting NCT05443009 - Self-Reported Pain in Children Submitted to Single Infiltration of Articaine During Primary Molar Extraction Phase 4
Terminated NCT02161354 - Safety and Efficacy Study of NTC-510 to Treat Pain Following Dental Surgery of Third Molars Phase 2
Completed NCT04949126 - Self Medication in Odontology (AUDE)
Completed NCT03652818 - Dental Pain Study of Analgesics in Patients Undergoing Molar Removal Phase 2