Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1386

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: AZD1386; Drug: Naproxen; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Naproxen	Drug: Naproxen; 500mg, capsule, single dose
Experimental: AZD1386	Drug: AZD1386; 95mg, oral solution, single dose
Placebo Comparator: Placebo; Placebo matching AZD1386	Drug: Placebo; AZD1386 Placebo oral solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sum of Pain Intensity Difference in Percent (SPID%)	Weighted sum of the pain intensity (PI) differences in percent for the given time frame. PI values are weighted according to the time since the previous PI assessment (or the time of administration of the investigational product for the first post-dose assessment). SPID% = elapsed since previous value, where is the PI difference in percent at assessment t. High values=good effect, low values=poor effect Pointwise assessments of pain are measured using a VAS scale (0-100 mm), as described in the secondary outcome measure (PI).	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)	0 = 'No pain' 100 ='Worst pain imaginable' Up to 16 individual assessments were performed and contained in the derived primary outcome measure, thus not reported separately.	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.
Time to First Perceptible Pain Relief	First perceptible pain relief is the time at which the participant begins to feel any pain relief at all. The time to first perceptible pain relief was reported by the participant using a stopwatch. Each time the watch is stopped, the participants will rate their pain intensity. Note: Participants who do not report first perceptible pain relief, and participants who report first perceptible pain relief after rescue intake, have the corresponding time censored to 8 hours.	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
Time to First Meaningful Pain Relief	First meaningful pain relief is the time when the participant's pain relief feels meaningful. The time to first meaningful pain relief will be reported by the participant using a stopwatch. Each time the watch is stopped, the participants will rate their pain intensity. Note: Participants who do not report first meaningful pain relief, and participants who report first meaningful pain relief after rescue intake, have the corresponding time censored to 8 hours.	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
VAS Pain Intensity at Rescue Intake	0 = 'No pain' 100 ='Worst pain imaginable'	at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product
VAS Pain on Jaw Movement at Rescue Intake	0 = 'No pain' 100 ='Worst pain imaginable'	at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Lynn Webster, MD, Lifetree Clinical Research3838 South, 700 East, Suite 202Salt Lake City, Utah 84106, USA; Study Chair: Bror Jonzon, AstraZeneca R&D Södertälje, SE-151 85 Södertälje, Sweden

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: May 1, 2008
• First Submitted That Met QC Criteria: May 5, 2008
• First Posted (Estimate): May 6, 2008

Study Record Updates

• Last Update Posted (Estimate): June 8, 2012
• Last Update Submitted That Met QC Criteria: May 7, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: Analgesic effect
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Naproxen
• Other Study ID Numbers: D5090C00010