Status:
COMPLETED
Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940
Lead Sponsor:
AstraZeneca
Conditions:
Low Back Pain
Eligibility:
All Genders
20-65 years
Phase:
PHASE1
Brief Summary
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 Administratio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00689780
Start Date
March 1 2008
End Date
November 1 2008
Last Update
December 10 2010
Active Locations (3)
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1
Research Site
Linköping, Sweden
2
Research Site
Luleå, Sweden
3
Research Site
Upssala, Sweden