NCT01200524

Brief Summary

A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with posttraumatic neuralgia.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
133

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2010

Shorter than P25 for phase_2

Geographic Reach
7 countries

25 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

First Submitted

Initial submission to the registry

September 10, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

September 25, 2013

Completed
Last Updated

April 25, 2014

Status Verified

April 1, 2014

Enrollment Period

1.5 years

First QC Date

September 10, 2010

Results QC Date

July 25, 2013

Last Update Submit

April 8, 2014

Conditions

Nerve Pain

Keywords

Analgesic effect

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Average Pain Score.

    Last Observation Carried Forward (LOCF). Twice daily, the participants rated their Average Pain intensity during the past 12 hours on an Numerical Rating Scale (NRS) scale 0-10. 0= No pain, 10= Worst pain imaginable.

    Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28

Secondary Outcomes (4)

  • Change From Baseline to Days 24-28 in Numerical Rating Scale (NRS) Worst Pain Score

    Baseline (mean of Day -5 to Day -1) to the mean of Day 24 to Day 28

  • Number of Participants With at Least 30% Decrease From Baseline in Numerical Rating Scale (NRS) Average Pain Score at Day 28.

    Baseline (mean of Day -5 to Day -1) to Day 28

  • Number of Participants With at Least 50% Decrease From Baseline in Numerical RatingScale (NRS) Average Pain Score at Day 28.

    Baseline (mean of Day -5 to Day -1) to Day 28

  • Change From Baseline to Day 29 in Neuropathic Pain Symptom Inventory Scal (NPSI) Total Score.

    Baseline (Day 1) to Day 29 (Visit 7)

Study Arms (3)

AZD2423, 20mg

EXPERIMENTAL
Drug: AZD2423

AZD2423, 150 mg

EXPERIMENTAL
Drug: AZD2423

Placebo

PLACEBO COMPARATOR

Tablet to match the 20 mg and 50 mg AZD2423 active tablet

Drug: Placebo

Interventions

AZD2423DRUG

20 mg tablet

AZD2423, 20mg
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of signed informed consent form
  • Males and female patients aged 18 to 80 years
  • Patients with neuropathic pain due to peripheral nerve injury caused by trauma or surgery

You may not qualify if:

  • Other paint that may confound assessment of neuropathic pain
  • History of treatment failure with more than three adequate trials of treatment for neuropathic pain
  • Central neuropathic pain conditions (caused by Central Nervous System injury/disease, eg. Stroke)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Research Site

Pleven, Bulgaria

Location

Research Site

Sofia, Bulgaria

Location

Research Site

Aalborg, Denmark

Location

Research Site

Odense, Denmark

Location

Research Site

Boulogne-Billancourt, France

Location

Research Site

Clermont-Ferrand, France

Location

Research Site

Nice, France

Location

Research Site

Saint-Priest-en-Jarez, France

Location

Research Site

Gdansk, Poland

Location

Research Site

Katowice, Poland

Location

Research Site

Krakow, Poland

Location

Research Site

Poznan, Poland

Location

Research Site

Tychy, Poland

Location

Research Site

Warsaw, Poland

Location

Research Site

Kazan', Russia

Location

Research Site

Moscow, Russia

Location

Research Site

Saint Petersburg, Russia

Location

Research Site

Ufa, Russia

Location

Research Site

Falköping, Sweden

Location

Research Site

Kristianstad, Sweden

Location

Research Site

Stockholm, Sweden

Location

Research Site

Birmingham, United Kingdom

Location

Research Site

Bradford, United Kingdom

Location

Research Site

Glasgow, United Kingdom

Location

Research Site

Manchester, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Heather Bryson
Organization
AstraZeneca
clinicaltrialtransparency@astrazeneca.com

Study Officials

  • Bror Jonzon

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2010

First Posted

September 13, 2010

Study Start

October 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

April 25, 2014

Results First Posted

September 25, 2013

Record last verified: 2014-04

Locations

SE(3)DK(2)BU(2)FR(4)RU(4)PL(6)GB(4)