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Study to Investigate the Effects Single Oral Dose of AZD1386 (Capsaicin)

Primary Purpose

Capsaicin Evoked Pain, Heat Sensitivity

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
AZD1386
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Capsaicin Evoked Pain focused on measuring Proof of Mechanism, Capsaicin evoked pain

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Clinical normal physical findings, including BP, pulse rate >45 bpm, ECG and laboratory assessments
  • Body Mass Index (BMI) of ≥18 to ≤30 kg/m2 and weight of ≥50 to ≤100 kg.
  • Non-fertile females

Exclusion Criteria:

  • History of hypersensitivity, allergy or atopic/skin disease as judged by Investigator.
  • History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the Investigator.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    36 subjects receiving a specified volume of the active component AZD1386 in a single dose.

    36 subjects receiving a specified volume of placebo in a single dose.

    Outcomes

    Primary Outcome Measures

    VAS, HPT

    Secondary Outcome Measures

    eVAS, HPT, Laser Doppler imaging,WDT, Somedic allodynia
    Vital signs, laboratory variables and adverse event each day throughout the study. paper printout ECG and/or digital ECG throughout the study. Pain evoked assessments visit 1-3
    Pharmacokinetics/Pharmacodynamics

    Full Information

    First Posted
    June 5, 2008
    Last Updated
    June 5, 2008
    Sponsor
    AstraZeneca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00692146
    Brief Title
    Study to Investigate the Effects Single Oral Dose of AZD1386 (Capsaicin)
    Official Title
    A Double-Blind, Randomized, Single-Centre, Placebo-Controlled, Crossover Study to Investigate the Effects of a Single Oral Dose of AZD1386 on Intradermal Capsaicin Evoked Pain Symptoms and Heat Sensitivity in Healthy Volunteers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    May 2008 (Actual)
    Study Completion Date
    May 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    AstraZeneca

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A double-blind, randomized, single-centre, placebo-controlled, crossover study to investigate the effects of a single oral dose of AZD1386 on intradermal capsaicin evoked pain symptoms and heat sensitivity in healthy volunteers

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Capsaicin Evoked Pain, Heat Sensitivity
    Keywords
    Proof of Mechanism, Capsaicin evoked pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    36 subjects receiving a specified volume of the active component AZD1386 in a single dose.
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    36 subjects receiving a specified volume of placebo in a single dose.
    Intervention Type
    Drug
    Intervention Name(s)
    AZD1386
    Intervention Description
    Oral solution fixed dose (95 mg given orally on two occasions)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Oral solution fixed dose (95 mg given orally on two occasions)
    Primary Outcome Measure Information:
    Title
    VAS, HPT
    Time Frame
    Visit 2-4
    Secondary Outcome Measure Information:
    Title
    eVAS, HPT, Laser Doppler imaging,WDT, Somedic allodynia
    Time Frame
    Visit 2-4
    Title
    Vital signs, laboratory variables and adverse event each day throughout the study. paper printout ECG and/or digital ECG throughout the study. Pain evoked assessments visit 1-3
    Time Frame
    Visit 1-5
    Title
    Pharmacokinetics/Pharmacodynamics
    Time Frame
    Visit 2-4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Clinical normal physical findings, including BP, pulse rate >45 bpm, ECG and laboratory assessments Body Mass Index (BMI) of ≥18 to ≤30 kg/m2 and weight of ≥50 to ≤100 kg. Non-fertile females Exclusion Criteria: History of hypersensitivity, allergy or atopic/skin disease as judged by Investigator. History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the Investigator.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Agneta Berg
    Organizational Affiliation
    AstraZeneca R&D Södertälje
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Ingemar Bylesjö
    Organizational Affiliation
    AstraZeneca R&D CPU Karolinska University Hospital, Stockholm
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Study to Investigate the Effects Single Oral Dose of AZD1386 (Capsaicin)

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