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Trial record 6 of 6 for:    "Autonomic Neuropathy" | "Hormones"

A Multicenter Study Comparing the Analgesic Effects and Safety of ABT-639 Compared to Placebo in Subjects With Diabetic Neuropathic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01345045
Recruitment Status : Completed
First Posted : April 29, 2011
Last Update Posted : January 8, 2013
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Tracking Information
First Submitted Date  ICMJE April 28, 2011
First Posted Date  ICMJE April 29, 2011
Last Update Posted Date January 8, 2013
Study Start Date  ICMJE April 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2011)
A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary [ Time Frame: Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study) ]
Daily questions asked on a hand held diary
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01345045 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2011)
  • Patient's Global Impression of Change [ Time Frame: Week 2, Week 4 and Week 6 (End of Study) ]
    Paper questionnaire
  • Brief Pain Inventory (BPI) (short form) including Severity and Interference [ Time Frame: At each visit up to Week 6 (end of Study) ]
    Paper questionnaire
  • Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Baseline, Week 2, Week 4 and Week 6 (end of Study) ]
    Paper questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter Study Comparing the Analgesic Effects and Safety of ABT-639 Compared to Placebo in Subjects With Diabetic Neuropathic Pain
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo and Active Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-639 to Placebo in Subjects With Diabetic Neuropathic Pain
Brief Summary People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Neuropathic Pain
Intervention  ICMJE
  • Drug: ABT-639
    ABT-639 Twice Daily for six weeks.
  • Drug: pregabalin
    pregabalin starting dose twice daily for 1 week then titrated to maintenance dose twice daily for the remainder of the study.
    Other Name: Lyrica
  • Drug: Placebo
    Placebo twice daily for 6 weeks.
Study Arms  ICMJE
  • Experimental: ABT-639
    ABT-639 twice daily for 6 weeks
    Intervention: Drug: ABT-639
  • Active Comparator: pregabalin
    pregabalin starting dose twice daily for week one then titrated up to maintenance dose twice daily for duration of the study
    Intervention: Drug: pregabalin
  • Placebo Comparator: Placebo
    Placebo twice daily for 6 weeks
    Intervention: Drug: Placebo
Publications * Ziegler D, Duan WR, An G, Thomas JW, Nothaft W. A randomized double-blind, placebo-, and active-controlled study of T-type calcium channel blocker ABT-639 in patients with diabetic peripheral neuropathic pain. Pain. 2015 Oct;156(10):2013-20. doi: 10.1097/j.pain.0000000000000263.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2011)
193
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2011)
180
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is between the ages of 18 to 75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months.
  • Subject must have an average score of greater than or equal to ( ≥) 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit.

Exclusion Criteria:

  • Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from Diabetic Neuropathic Pain (DNP) or interfere with the pain assessments of DNP.
  • A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with DNP assessments or other functions.
  • Subject has clinically significant abnormalities in clinical laboratory tests.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czech Republic,   France,   Germany,   Mexico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01345045
Other Study ID Numbers  ICMJE M11-891
2010-024359-99 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AbbVie ( AbbVie (prior sponsor, Abbott) )
Study Sponsor  ICMJE AbbVie (prior sponsor, Abbott)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rachel Duan, MD AbbVie
PRS Account AbbVie
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP