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

• ClinicalTrials.gov Identifier: NCT00672646
• Recruitment Status: Completed
• First Posted: May 6, 2008
• Results First Posted: June 8, 2012
• Last Update Posted: June 8, 2012
• Sponsor: AstraZeneca
• Information provided by (Responsible Party): AstraZeneca

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: AZD1386; Drug: Naproxen; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 103 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, 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
• Study Start Date: April 2008
• Actual Primary Completion Date: June 2008
• Actual Study Completion Date: June 2008

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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 :

1. 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. ]
   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.
2. 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 ]
   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.
3. 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 ]
   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.
4. 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 ]
   0 = 'No pain' 100 ='Worst pain imaginable'
5. 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 ]
   0 = 'No pain' 100 ='Worst pain imaginable'

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT00672646
• Other Study ID Numbers: D5090C00010
• First Posted: May 6, 2008
• Results First Posted: June 8, 2012
• Last Update Posted: June 8, 2012
• Last Verified: May 2012

Keywords provided by AstraZeneca:

Analgesic effect

Additional relevant MeSH terms:

Naproxen; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Gout Suppressants; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action