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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01201317
First received: September 13, 2010
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Neuropathic Pain
Drug: AZD2423
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Investigate the Analgesic Efficacy of AZD2423 Compared With Placebo

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]

    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)


  • 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 ] [ Designated as safety issue: No ]

    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)


  • 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 134
Study Start Date: September 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD2423, 150 mg
Tablets, 150 mg once daily in the morning.
Drug: AZD2423
150 mg tablet
Experimental: AZD2423, 20 mg
Tablets, 20 mg once daily in the morning.
Drug: AZD2423
20 mg tablet
Placebo Comparator: Placebo
Tablets, placebo, once daily in the morning.
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201317

Locations
United States, Arizona
Research Site
Goodyear, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Tucson, Arizona, United States
United States, California
Research Site
Los Angeles, California, United States
United States, Florida
Research Site
Deland, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Sunrise, Florida, United States
United States, Kentucky
Research Site
Madisonville, Kentucky, United States
United States, New Jersey
Research Site
Willingboro, New Jersey, United States
United States, New York
Research Site
New York, New York, United States
United States, North Carolina
Research Site
Winston-salem, North Carolina, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
United States, Texas
Research Site
Houston, Texas, United States
Canada, Manitoba
Research Site
Winnipeg, Manitoba, Canada
Canada, Ontario
Research Site
Brampton, Ontario, Canada
Research Site
Etobicoke, Ontario, Canada
Research Site
Mississauga, Ontario, Canada
Canada, Quebec
Research Site
Lachine, Quebec, Canada
Canada
Research Site
Laval, Canada
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Bror Jonzon AstraZeneca R&D Södertälje
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01201317     History of Changes
Other Study ID Numbers: D2600C00005
Study First Received: September 13, 2010
Results First Received: July 25, 2013
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by AstraZeneca:
Analgesic effect

Additional relevant MeSH terms:
Neuralgia
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms
Analgesics
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014