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

NCT ID: NCT00692146

Last Updated: 2008-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Capsaicin Evoked Pain Heat Sensitivity

Keywords

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Proof of Mechanism Capsaicin evoked pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

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

Group Type EXPERIMENTAL

AZD1386

Intervention Type DRUG

Oral solution fixed dose (95 mg given orally on two occasions)

2

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral solution fixed dose (95 mg given orally on two occasions)

Interventions

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AZD1386

Oral solution fixed dose (95 mg given orally on two occasions)

Intervention Type DRUG

Placebo

Oral solution fixed dose (95 mg given orally on two occasions)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca R&D Södertälje

Principal Investigators

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Agneta Berg

Role: STUDY_CHAIR

AstraZeneca R&D Södertälje

Ingemar Bylesjö

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca R&D CPU Karolinska University Hospital, Stockholm

Other Identifiers

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D5090C00009

Identifier Type: -

Identifier Source: org_study_id