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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00672646
• Other study ID #: D5090C00010
• Status: Completed
• Phase: Phase 2
• First received: May 1, 2008
• Last updated: May 7, 2012
• Start date: April 2008
• Est. completion date: June 2008

Study information

• Verified date: May 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• AZD1386
95mg, oral solution, single dose
• Naproxen
500mg, capsule, single dose
• Placebo
AZD1386 Placebo oral solution

Locations

Country	Name	City	State
United States	Research Site	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No