Clinical trial NCT00672646: Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1386
Official title: A Double-blind, Randomized, Placebo and Naproxen Controlled Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1386, in Patients Undergoing Impacted Mandibular Third Molar Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: Analgesic effect
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-06
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to investigate if AZD1386 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain. A number of patients will instead receive the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen, will be allowed if a need for additional painkillers would arise. A number of patients will receive naproxen as control.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for surgical removal of one partial or complete impacted mandibular third molar.
* Provision of signed informed consent.

Exclusion Criteria:

* History of somatic disease/condition, which may interfere with the objectives for the study, as judged by the investigator.
* Clinically significant illness or clinically relevant trauma within the 2 weeks prior to the administration of the investigational product, as judged by the investigator.
* A family history of short QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first degree relatives
* Patients with a body temperature \>37.5°C at Visit 2, before start of surgical procedures

Primary outcomes:
measure: Sum of Pain Intensity Difference in Percent (SPID%)
timeFrame: from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours
Secondary outcomes:
measure: Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)
timeFrame: Immediately prior to administration of investigational product (IP). After intake of IP assessment will be made every 15 min for the first 2 h, at 2h and 30 min, 3 h and thereafter every hour up to 8 h after intake of IP.
measure: Time to First Perceptible Pain Relief
timeFrame: from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours
measure: Time to First Meaningful Pain Relief
timeFrame: from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours
measure: VAS Pain Intensity at Rescue Intake
timeFrame: at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product
measure: VAS Pain on Jaw Movement at Rescue Intake
timeFrame: at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
Study officials:
affiliation: Lifetree Clinical Research3838 South, 700 East, Suite 202Salt Lake City, Utah 84106, USA
name: Lynn Webster, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D Södertälje, SE-151 85 Södertälje, Sweden
name: Bror Jonzon
role: STUDY_CHAIR
References: