Skip to main content
OpenTrials
Completed

NCT Number: NCT01201317

A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo After 28 Days Treatment in Patients With Painful Diabetic Polyneuropathy

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neuropathic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Winnipeg, Manitoba, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

AZD2423

Drug

20 mg tablet

Placebo

Drug

Placebo

Primary outcomes

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

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

    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.

Secondary outcomes

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

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

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

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

    Time frame: Baseline (mean of Day -5 to Day -1) to Day 28

    Last Observation Carried Forward (LOCF). Numerical Rating Scale(NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)*100.

    Responder= NRS Average Pain score reduction ≥30% (yes/no)

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

    Time frame: Baseline (mean of Day -5 to Day -1) to Day 28

    Last Observation Carried Forward (LOCF). Numerical Rating Scale (NRS) Average Pain score reduction=(change from baseline at Day 28/baseline)*100.

    Responder= NRS Average Pain score reduction ≥50% (yes/no)

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

    Time frame: Baseline (Day 1) to Day 29 (Visit 7)

    Last Observation carried Forward (LOCF). Scale consists of 10 Neuropathic Pain Symptom Inventory Scale (NPSI) pain symptom descriptors wiht a recall period of 24 hours. Each descriptor is rated on a Numerical Rating Scale (NRS) 0-10; 0=No (symptom), 10=Worst (symptom) imaginable. The NPSI Total Score was calculated as the sum of 10 of the NPSI descriptors. Range for total score 0 -100. Higher total score implicates worse symptoms.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 14, 2010
Registry last updated
Apr 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.