Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689780
• Other study ID #: D3120C00003
• Status: Completed
• Phase: Phase 1
• First received: May 30, 2008
• Last updated: December 8, 2010
• Start date: March 2008
• Est. completion date: November 2008

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencySweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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 Administration of Oral Multiple Ascending Doses in Adult Subjects with Chronic Low Back Pain

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• AZD1940
Oral solution Multiple ascending dose given orally once daily at day 1-12
• Midazolam
Oral solution given orally once daily on day -1 and day 14

Locations

Country	Name	City	State
Sweden	Research Site	Linkoping
Sweden	Research Site	Lulea
Sweden	Research Site	Upssala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of adverse events (AEs) occurring during the study, blood pressure (supine and standing), pulse rate, respiratory rate, body temperature, laboratory variables and ECG		Vital signs, laboratory variables and adverse event each day throughout the study Paper printout ECG and/or digital ECG throughout the study	No
Secondary	Assessment of psychometric rating scales ( VAMS, CDR test battery, DEQ, ARCI and Bond-Lader)		Psychometric tests and VAMS (Visual Analogue Mood Scale) throughout the study	No
Secondary	To investigate the PK profile (including dose proportionality) of AZD1940 by assessment of plasma concentrations		Bloodsampling Day 1,6, 10 and 15	No
Secondary	Plasma levels of midazolam and 4ß hydroxycholesterol and 6ß hydroxycortisol:cortisol urine excretion ratio as markers		Bloodsampling at day -1, 14	No