Clinical trial NCT00659490: Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1940
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: Analgesic effect
Molar extraction
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-16
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Pain Area Under the Curve 0-8h (AUC0-8h)
timeFrame: 0-8 h(from end of surgery to 8 hours post surgery)
Secondary outcomes:
measure: Pain Area Under the VAS Versus Time Curve 0-4h (AUC0-4h)
timeFrame: 0-4h (from end of surgery to 4 hours post surgery)
measure: Maximum Pain Based on VAS Scale
timeFrame: From end of surgery to 8h or time first intake of rescue medication (whichever came first)
measure: Mean Pain Based on a VAS Scale
timeFrame: From end of surgery to 8h or time to first intake of rescue medication (whichever came first)
measure: Pain at Jaw Movement AUC0-8h
timeFrame: 0-8h from end of surgery to 8 hours post surgery
measure: Pain at Jaw Movement AUC0-4h
timeFrame: 0-4h after end of surgery to 4 hours post surgery
measure: Maximum Pain at Jaw Movement
timeFrame: From end of surgery to 8h or time to first intake of rescue medication (whichever came first)
measure: Mean Pain at Jaw Movement
timeFrame: From end of surgery to 8h or time to first intake of rescue medication (whichever came first)
measure: Pain at Rescue Medication
timeFrame: At time of first rescue medication taken before 8 hours after end of surgery
measure: Pain at Jaw Movement at Time of First Rescue Medication
timeFrame: At time of first rescue medication (before 8 hours after end on surgery)
measure: Time to First Intake of Rescue Medication.
timeFrame: From end of surgery to 8 hours following surgery
measure: Number of Patients Requesting Rescue Medication
timeFrame: End of surgery up to 8hours following surgery
measure: Maximum Deterioration in Visual Analogue Mood Scale (VAMS) Stimulated
timeFrame: Between dosing and 12h post-dose
measure: Maximum Deterioration in VAMS High
timeFrame: Between dosing and 12h post-dose
measure: Maximum Deterioration in VAMS Anxious
timeFrame: Between dosing and 12h post-dose
measure: Maximum Deterioration in VAMS Sedated
timeFrame: Between dosing and 12h post-dose
measure: Maximum Deterioration in VAMS Down
timeFrame: Between dosing and 12h post-dose
measure: Time to Max Deterioration in VAMS Stimulated
timeFrame: Between dosing and 12h post-dose
measure: Time to Max Deterioration in VAMS High
timeFrame: Between dosing and 12h post-dose
measure: Time to Max Deterioration in VAMS Anxious
timeFrame: Between dosing and 12h post-dose
measure: Time to Max Deterioration in VAMS Sedated
timeFrame: Between dosing and 12h post-dose
measure: Time to Max Deterioration in VAMS Down
timeFrame: Between dosing and 12h post-dose
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
Study officials:
affiliation: Lifetree Clinical Research3838 South, 700 East, Suite 202Salt Lake City, Utah 84106, USA
name: Lynn Webster, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D Södertälje, SE-151 85 Södertälje, Sweden
name: Bror Jonzon
role: STUDY_CHAIR
References: