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

Last updated: January 26, 2021
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Overall Status: Completed

Phase

3

Condition

Pain

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT01332149
A0081265
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female subjects aged 18 years or older
  • Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due todiabetes mellitus (Type 1 or 2), and symptoms of painful diabetic neuropathy for 6months to 5 years (inclusive).
  • At the baseline and randomization visits, a score of ≥50 mm on the Visual AnalogueScale, at randomization, subjects must have completed at least 5 daily paininterference 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

Exclusion Criteria:

  • Subjects with more than 30% decrease on the Pain Visual Analog Scale at randomizationas compared to screening; and during the 1 week screening period, with more than onepain score <3 in pain scores.
  • Subject has other kinds of neurological disorder, pain of other reason, or skincondition that could confuse the assessment.
  • Subject with any other serious or unstable condition which in the opinion of theinvestigator might compromise participation in the study.

Study Design

Total Participants: 626
Study Start date:
July 01, 2011
Estimated Completion Date:
June 30, 2014

Connect with a study center

  • Southwest hospital of the third military medical university/Department of Neurology

    Chongqing, Chongqing 400038
    China

    Site Not Available

  • Fuzhou General Hospital of Nanjing Military Command

    Fuzhou, Fujian 350025
    China

    Site Not Available

  • Department of Endocrinology, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong 510120
    China

    Site Not Available

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong 510260
    China

    Site Not Available

  • Dept. of Endocrinology, The first Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150001
    China

    Site Not Available

  • Dept. of Endocrinology, The second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang 150086
    China

    Site Not Available

  • Tongji Hospital,Tongji Medical College Huazhong University of Science & Technology

    Wuhan, Hubei 430030
    China

    Site Not Available

  • Xiangya Hospital of Centre-south University

    Changsha, Hunan 410008
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Dept. of Endocrinology, The second hospital of Jilin University

    Changchun, Jilin 130041
    China

    Site Not Available

  • Shengjing hospital of china medical university

    Shenyang, Liaoning 110004
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Site Not Available

  • Qilu Hospital of Shandong University/department of internal neurology

    Jinan, Shandong 250012
    China

    Site Not Available

  • First Hospital of Shanxi Medical University

    Taiyuan City, Shanxi 030001
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • Sir Run Run Shaw Hospital, School of medicine, Zhejiang University

    Hangzhou, Zhejiang 310016
    China

    Site Not Available

  • The Second Affiliated Hospital Zhejiang University College of Medicine

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

  • Beijing Hospital of the Ministry of Health

    Beijing, 100730
    China

    Site Not Available

  • Beijing Tiantan Hospital affiliated to Capital Medical University, Neurology Department

    Beijing, 100050
    China

    Site Not Available

  • Chinese PLA General Hospital

    Beijing, 100853
    China

    Site Not Available

  • Endocrinology Department

    Beijing, 100700
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, 100191
    China

    Site Not Available

  • Tongren Hospital Affiliated to Capital Medical University

    Beijing, 100730
    China

    Site Not Available

  • GuangZhou First Municipal People's Hospital

    Guangzhou, 510180
    China

    Site Not Available

  • Huashan Hospital Affiliated Fudan University, Neurology Department

    Shang Hai, 200040
    China

    Site Not Available

  • Renji Hospital Shanghai Jiao Tong University School of Medicine/Neurology Department

    Shanghai, 200127
    China

    Site Not Available

  • Shanghai Changzheng Hospital

    Shanghai, 200003
    China

    Site Not Available

  • Shanghai First People's Hospital

    Shanghai, 200080
    China

    Site Not Available

  • Shanghai Tenth People's Hospital/The Endocrinology Department

    Shanghai, 200072
    China

    Site Not Available

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