Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1940 - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00659490

Purpose

The primary aim of this study is to investigate if AZD1940 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1940 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: AZD1940 Drug: Naproxen	Phase II

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 Randomised, Double Blind, Placebo-Controlled Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1940, 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:

To investigate the analgesic effect of AZD1940 800ug compared to placebo in dental surgery patients following impacted mandibular third molar extraction. [ Designated as safety issue: No ]

Secondary Outcome Measures:

To investigate the effects of orally administered AZD1940; the safety and tolerability of orally administered AZD1940; the pharmacokinetics of AZD1940 and the pharmacokinetic/pharmacodynamics of orally administered AZD1940. [ Designated as safety issue: Yes ]

Enrollment:	151
Study Start Date:	February 2008
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: AZD1940 800ug oral administration
Active Comparator: 2	Drug: Naproxen 500mg oral administration Other Name: Naprosyn

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.
Healthy males or non-fertile females.

Exclusion Criteria:

History of somatic disease/condition, which may interfere with the objectives of the study, as judged by the investigator.
History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorder, 4th edition.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659490

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

ClinicalTrials.gov Identifier:	NCT00659490 History of Changes
Other Study ID Numbers:	D3120C00006
Study First Received:	April 10, 2008
Last Updated:	July 9, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Analgesic effect
Molar extraction

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 February 09, 2012