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Completed

NCT Number: NCT00672646

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site

Salt Lake City, Utah, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1386

Drug

95mg, oral solution, single dose

Naproxen

Drug

500mg, capsule, single dose

Placebo

Drug

AZD1386 Placebo oral solution

Primary outcomes

  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 outcomes

  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'

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 6, 2008
Registry last updated
Jun 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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