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Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940

NCT ID: NCT00689780

Last Updated: 2010-12-10

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-11-30

Brief Summary

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A Phase I, Multi-Centre, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940, Including an Interaction Study, After Administration of Oral Multiple Ascending Doses in Adult Subjects with Chronic Low Back Pain

Detailed Description

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Conditions

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Low Back Pain

Keywords

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Pain safety chronic low back pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

AZD1940 + Placebo

Group Type EXPERIMENTAL

AZD1940

Intervention Type DRUG

Oral solution Multiple ascending dose given orally once daily at day 1-12

2

Group Type OTHER

Midazolam

Intervention Type DRUG

Oral solution given orally once daily on day -1 and day 14

Interventions

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AZD1940

Oral solution Multiple ascending dose given orally once daily at day 1-12

Intervention Type DRUG

Midazolam

Oral solution given orally once daily on day -1 and day 14

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* A diagnosis of Chronic Low Back Pain according to Quebec Task force Class 1-3 and an average pain intensity score of 3-9 on NRS(0-10) during the past week.
* Clinical normal physical findings, including blood pressure, pulse rate \> 45bpm, ECG (with normal QTcF interval \<450msec and without any additional risk factors for Torsades de Pointes) and laboratory assessments, as judged by investigator
* Body Mass Index (BMI) ≥18 to ≤32 kg/m2 inclusive and body weight ≥50 to ≤100 kg

Exclusion Criteria

* History of somatic disease/condition which may interfere with the objectives of the study, with the exception of Chronic Low Back Pain
* History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder
* Clinically significant illness with the exception of Chronic Low Back Pain
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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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Janet Post

Role: STUDY_CHAIR

AstraZeneca R&D SödertäljeSE

Wolfgang Kühn

Role: PRINCIPAL_INVESTIGATOR

Quintiles AB Phase 1 Services Strandbodgatan Uppsala, Sweden+

Locations

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Research Site

Linköping, , Sweden

Site Status

Research Site

Luleå, , Sweden

Site Status

Research Site

Upssala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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D3120C00003

Identifier Type: -

Identifier Source: org_study_id