Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1386 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Pain	Drug: AZD1386 Drug: Naproxen Drug: Placebo	Phase 2

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

Resource links provided by NLM:

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Sum of Pain Intensity Difference in Percent (SPID%) [ Time Frame: 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 ] [ Designated as safety issue: No ]
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:

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

Enrollment:	103
Study Start Date:	April 2008
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AZD1386	Drug: AZD1386 95mg, oral solution, single dose
Active Comparator: Naproxen	Drug: Naproxen 500mg, capsule, single dose
Placebo Comparator: Placebo Placebo matching AZD1386	Drug: Placebo AZD1386 Placebo oral solution

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672646

Locations

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

Sponsors and Collaborators

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

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00672646 History of Changes
Other Study ID Numbers:	D5090C00010
Study First Received:	May 1, 2008
Results First Received:	August 31, 2011
Last Updated:	May 7, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Analgesic effect

Additional relevant MeSH terms:

Analgesics
Naproxen
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013