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

Condition(s) targeted: Diabetic Neuropathy, Painful

Intervention: Pregabalin (Drug); Placebo matched with pregabalin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

Official title: 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 With Pain Associated With Diabetic Peripheral Neuropathy.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Endpoint mean pain score based on the pain scores from the subject's daily pain rating scale

Secondary outcome:

Weekly mean pain scores from the subject's daily pain rating scale

Weekly mean sleep interference scores from the subject's daily sleep interference scale

Responder rates with at least a 30% reduction from baseline in weekly mean pain score

Change from baseline in Short-Form McGill Pain Questionnaire at week 9

Change from baseline in Pain Visual Analogue Scale at week 9

Change from baseline in Medical Outcomes Study -Sleep Scale at week 9

The Subject Global Impression of Change at week 9

The Clinical Global Impression of Change at week 9

Change from baseline in Hospital Anxiety and Depression Scale at week 9

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Chinese PLA General Hospital, Beijing 100853, China; Recruiting

Endocrinology Department, Beijing 100700, China; Recruiting

Beijing Tiantan Hospital affiliated to Capital Medical University, Neurology Department, Beijing 100050, China; Recruiting

Beijing Hospital of the Ministry of Health, Beijing 100730, China; Recruiting

Peking University Third Hospital, Beijing 100191, China; Recruiting

Tongren Hospital Affiliated to Capital Medical University, Beijing 100730, China; Recruiting

GuangZhou First Municipal People's Hospital, Guangzhou 510180, China; Recruiting

Huashan Hospital Affiliated Fudan University, Neurology Department, Shang Hai 200040, China; Recruiting

Shanghai Changzheng Hospital, Shanghai 200003, China; Recruiting

Renji Hospital Shanghai Jiao Tong University School of Medicine/Neurology Department, Shanghai 200127, China; Recruiting

Shanghai First People's Hospital, Shanghai 200080, China; Recruiting

Southwest hospital of the third military medical university/Department of Neurology, Chongqing, Chongqing 400038, China; Not yet recruiting

Dept. of Endocrinology, The first Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang 150001, China; Recruiting

Dept. of Endocrinology, The second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang 150086, China; Recruiting

Tongji Hospital,Tongji Medical College Huazhong University of Science & Technology, Wuhan, Hubei 430030, China; Recruiting

Jiangsu Province Hospital, Nanjing, Jiangsu 210029, China; Recruiting

The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi 330006, China; Recruiting

Dept. of Endocrinology, The second hospital of Jilin University, Changchun, Jilin 130041, China; Recruiting

Qilu Hospital of Shandong University, Jinan, Shandong 250012, China; Recruiting

Qilu Hospital of Shandong University/department of internal neurology, Jinan, Shandong 250012, China; Recruiting

Sir Run Run Shaw Hospital, School of medicine, Zhejiang University, Hangzhou, Zhejiang 310016, China; Recruiting

The Second Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, Zhejiang 310009, China; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: July 2011
Last updated: January 29, 2013