NCT00689780

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_1 low-back-pain

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_1 low-back-pain

Geographic Reach
1 country

3 active sites

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

March 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

December 10, 2010

Status Verified

December 1, 2010

Enrollment Period

8 months

First QC Date

May 30, 2008

Last Update Submit

December 8, 2010

Conditions

Low Back Pain

Keywords

Painsafetychronic low back pain

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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

  • To investigate the PK profile (including dose proportionality) of AZD1940 by assessment of plasma concentrations

    Bloodsampling Day 1,6, 10 and 15

  • Plasma levels of midazolam and 4ß hydroxycholesterol and 6β hydroxycortisol:cortisol urine excretion ratio as markers

    Bloodsampling at day -1, 14

Study Arms (2)

1

EXPERIMENTAL

AZD1940 + Placebo

Drug: AZD1940

2

OTHER
Drug: Midazolam

Interventions

AZD1940DRUG

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

1
MidazolamDRUG

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

2

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Linköping, Sweden

Location

Research Site

Luleå, Sweden

Location

Research Site

Upssala, Sweden

Location

MeSH Terms

Conditions

Low Back PainPain

Interventions

N-(2-tert-butyl-1-((4,4-difluorocyclohexyl)methyl)-1H-benzo(d)imidazol-5-yl)ethanesulfonamideMidazolam

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Janet Post

    AstraZeneca R&D SödertäljeSE

    STUDY CHAIR

  • Wolfgang Kühn

    Quintiles AB Phase 1 Services Strandbodgatan Uppsala, Sweden+

    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
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 30, 2008

First Posted

June 4, 2008

Study Start

March 1, 2008

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

December 10, 2010

Record last verified: 2010-12

Locations

SE(3)