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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00672646

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study
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: 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 ]

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 ]
Time to first perceptible pain relief and time to first meaningful pain relief (based on stopwatches) [ Time Frame: The time of first perceptible pain relief/meaningful pain relief after intake of IP will be reported by the patients by stopping the stopwatch. ] [ Designated as safety issue: No ]
Visual Analogue Scale (VAS) pain intensity at rescue intake [ Time Frame: Immediately before the intake of rescue medication, VAS pain intensity and VAS pain on jaw movement will be assessed. ] [ Designated as safety issue: No ]

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
1: Experimental	Drug: AZD1386 95mg, oral solution, single dose
2: Active Comparator	Drug: Naproxen 500mg, capsule, single dose
3: Placebo Comparator Placebo	Drug: Placebo

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 R&D Södertälje, Sweden ( Rolf Karlsten, MD, PhD, Medical Science Director, Emerging Analgesia )
Study ID Numbers:	D5090C00010
Study First Received:	May 1, 2008
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00672646 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Analgesic effect

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Naproxen
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Gout Suppressants
Pharmacologic Actions

Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010