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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00689780 |
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Date of registration:
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30/05/2008 |
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Primary sponsor: |
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Public title:
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Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940
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Scientific title:
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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 |
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Date of first enrolment:
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March 2008 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00689780 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Janet Post |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca R&D SödertäljeSE |
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Name:
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Wolfgang Kühn |
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Address:
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Telephone:
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Email:
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Affiliation:
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Quintiles AB Phase 1 Services Strandbodgatan Uppsala, Sweden+ |
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Key inclusion & exclusion 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
Age minimum:
20 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Low Back Pain
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Intervention(s)
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Drug: AZD1940
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Drug: Midazolam
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Primary Outcome(s)
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Assessment of adverse events (AEs) occurring during the study, blood pressure (supine and standing), pulse rate, respiratory rate, body temperature, laboratory variables and ECG
[Time Frame: Vital signs, laboratory variables and adverse event each day throughout the study Paper printout ECG and/or digital ECG throughout the study]
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Secondary Outcome(s)
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Assessment of psychometric rating scales ( VAMS, CDR test battery, DEQ, ARCI and Bond-Lader)
[Time Frame: Psychometric tests and VAMS (Visual Analogue Mood Scale) throughout the study]
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Plasma levels of midazolam and 4ß hydroxycholesterol and 6ß hydroxycortisol:cortisol urine excretion ratio as markers
[Time Frame: Bloodsampling at day -1, 14]
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To investigate the PK profile (including dose proportionality) of AZD1940 by assessment of plasma concentrations
[Time Frame: Bloodsampling Day 1,6, 10 and 15]
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Secondary ID(s)
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D3120C00003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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