NCT01201317

Brief Summary

A study to investigate the analgesic efficacy of AZD2423 compared with placebo after 28 days treatment in patients with painful diabetic polyneuropathy.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_2

Geographic Reach
2 countries

20 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

September 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
2.3 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

9 months

First QC Date

September 13, 2010

Results QC Date

July 25, 2013

Last Update Submit

April 8, 2014

Conditions

Neuropathic 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) 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 Rating Scale (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 Scale (NPSI) Total Score.

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

Study Arms (3)

AZD2423, 150 mg

EXPERIMENTAL

Tablets, 150 mg once daily in the morning.

Drug: AZD2423

AZD2423, 20 mg

EXPERIMENTAL

Tablets, 20 mg once daily in the morning.

Drug: AZD2423

Placebo

PLACEBO COMPARATOR

Tablets, placebo, once daily in the morning.

Drug: Placebo

Interventions

AZD2423DRUG

20 mg tablet

AZD2423, 20 mg
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 of non-child bearing potential patients aged 18 to 80 years
  • Patients with neuropathic pain due to painful diabetic polyneuropathy.

You may not qualify if:

  • Other pain that may confound assessment of neuropathic pain
  • History of treatment failure with more than three adequate trials of medication 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 (20)

Research Site

Goodyear, Arizona, United States

Location

Research Site

Phoenix, Arizona, United States

Location

Research Site

Tucson, Arizona, United States

Location

Research Site

Los Angeles, California, United States

Location

Research Site

DeLand, Florida, United States

Location

Research Site

Miami, Florida, United States

Location

Research Site

Orlando, Florida, United States

Location

Research Site

Sunrise, Florida, United States

Location

Research Site

Madisonville, Kentucky, United States

Location

Research Site

Willingboro, New Jersey, United States

Location

Research Site

New York, New York, United States

Location

Research Site

Winston-Salem, North Carolina, United States

Location

Research Site

Philadelphia, Pennsylvania, United States

Location

Research Site

Houston, Texas, United States

Location

Research Site

Winnipeg, Manitoba, Canada

Location

Research Site

Brampton, Ontario, Canada

Location

Research Site

Etobicoke, Ontario, Canada

Location

Research Site

Mississauga, Ontario, Canada

Location

Research Site

Lachine, Quebec, Canada

Location

Research Site

Laval, Canada

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 R&D Södertälje

    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 13, 2010

First Posted

September 14, 2010

Study Start

September 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

April 25, 2014

Results First Posted

September 25, 2013

Record last verified: 2014-04

Locations

CA(6)US(14)