NCT00692146

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 5, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
Last Updated

June 6, 2008

Status Verified

June 1, 2008

Enrollment Period

4 months

First QC Date

June 5, 2008

Last Update Submit

June 5, 2008

Conditions

Capsaicin Evoked PainHeat Sensitivity

Keywords

Proof of MechanismCapsaicin evoked pain

Outcome Measures

Primary Outcomes (1)

  • VAS, HPT

    Visit 2-4

Secondary Outcomes (3)

  • eVAS, HPT, Laser Doppler imaging,WDT, Somedic allodynia

    Visit 2-4

  • 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

    Visit 1-5

  • Pharmacokinetics/Pharmacodynamics

    Visit 2-4

Study Arms (2)

1

EXPERIMENTAL

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

Drug: AZD1386

2

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

AZD1386DRUG

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

1
PlaceboDRUG

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

2

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

AZD1386

Study Officials

  • Agneta Berg

    AstraZeneca R&D Södertälje

    STUDY CHAIR

  • Ingemar Bylesjö

    AstraZeneca R&D CPU Karolinska University Hospital, Stockholm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 5, 2008

First Posted

June 6, 2008

Study Start

January 1, 2008

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

June 6, 2008

Record last verified: 2008-06