Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy

NCT01332149

Last updated date
Study Location
Southwest hospital of the third military medical university/Department of Neurology
Chongqing, Chongqing, 400038, China
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Painful Diabetic Neuropathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and female subjects aged 18 years or older

- Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes mellitus (Type 1 or 2), and symptoms of painful diabetic neuropathy for 6 months to 5 years (inclusive).

- At the baseline and randomization visits, a score of ≥50 mm on the Visual Analogue Scale, at randomization, subjects must have completed at least 5 daily pain interference diaries, and have an average daily pain score of ≥5 over the past 7 days.

- Patient who are willing and capable to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

- Women of childbearing potential are willing to use contraception during study.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Subjects with more than 30% decrease on the Pain Visual Analog Scale at randomization
as compared to screening; and during the 1 week screening period, with more than one
pain score <3 in pain scores.


- Subject has other kinds of neurological disorder, pain of other reason, or skin
condition that could confuse the assessment.


- Subject with any other serious or unstable condition which in the opinion of the
investigator might compromise participation in the study.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy
Official Title  ICMJE An 11-week Randomized, Double-blind, Multi Center, Placebo-controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (300 Mg/Day) Using A Fixed Dosing Schedule In The Treatment Of Subjects S With Pain Associated With Diabetic Peripheral Neuropathy.
Brief Summary

Pregabalin has proven effective in previous clinical trails in other countries in relieving neuropathic pain associated with postherpetic neuralgia and painful diabetic neuropathy.

This study is being conducted according to China registration requirement to submit a reapplication with new local diabetic peripheral neuropathy study as a commitment plus the existing data to apply for Lyrica "pain associated with postherpetic neuralgia" indication after Lyrica "pain associated with postherpetic neuralgia" is approved.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Neuropathy, Painful
Intervention  ICMJE
  • Drug: Pregabalin

    Subjects in the pregabalin group will start treatment with pregabalin capsule 150 mg/day for 1 week, then their dose will be increased to 300mg/day. After 1-week titration period, dose must be stable during study, no dose adjustment is permitted, and subject who cannot tolerate 300 mg/day pregabalin will be withdrawn.

    At the completion of the dose maintenance phase subjects will taper off study medication over a 1-week period. 300 mg/ day subjects will taper to 150 mg/ day.

  • Drug: Placebo matched with pregabalin
    Subject will take placebo matched with pregabalin twice a day.
Study Arms  ICMJE
  • Experimental: 300 mg/day pregabalin (Lyrica)
    Patient take pregabalin capsule twice a day
    Intervention: Drug: Pregabalin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo matched with pregabalin
Publications * Not Provided

*   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: June 27, 2014)
626
Original Estimated Enrollment  ICMJE
 (submitted: April 7, 2011)
612
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female subjects aged 18 years or older
  • Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes mellitus (Type 1 or 2), and symptoms of painful diabetic neuropathy for 6 months to 5 years (inclusive).
  • At the baseline and randomization visits, a score of ?50 mm on the Visual Analogue Scale, at randomization, subjects must have completed at least 5 daily pain interference diaries, and have an average daily pain score of ?5 over the past 7 days.
  • Patient who are willing and capable to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Women of childbearing potential are willing to use contraception during study.

Exclusion Criteria:

  • Subjects with more than 30% decrease on the Pain Visual Analog Scale at randomization as compared to screening; and during the 1 week screening period, with more than one pain score <3 in pain scores.
  • Subject has other kinds of neurological disorder, pain of other reason, or skin condition that could confuse the assessment.
  • Subject with any other serious or unstable condition which in the opinion of the investigator might compromise participation in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01332149
Other Study ID Numbers  ICMJE A0081265
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2015

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