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

Phase 2

Completed

Conditions: Pain

Interventions: Drug: AZD1386
Drug: Naproxen
Drug: Placebo

Registration Number: NCT00672646

Lead Sponsor: AstraZeneca

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 103

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD1386	AZD1386	-
Naproxen	Naproxen	-
Placebo	Placebo	Placebo matching AZD1386

Primary Outcome Measures

Name	Time	Method
Sum of Pain Intensity Difference in Percent (SPID%)	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	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).

Secondary Outcome Measures

Name	Time	Method
Time to First Meaningful Pain Relief	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	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.
Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)	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.	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.
Time to First Perceptible Pain Relief	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	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.
VAS Pain Intensity at Rescue Intake	at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product	0 = 'No pain' 100 ='Worst pain imaginable'
VAS Pain on Jaw Movement at Rescue Intake	at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product	0 = 'No pain' 100 ='Worst pain imaginable'