Clinical trial NCT01332149: Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy
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 S With Pain Associated With Diabetic Peripheral Neuropathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Neuropathy, Painful
Keywords: Diabetic Neuropathies
Pain
Efficacy of pregabalin
Placebo controlled
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-04-08
Enrollment: 626
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Baseline Mean Pain Score
timeFrame: Baseline
measure: Change From Baseline in Mean Pain Score at Endpoint
timeFrame: Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)
Secondary outcomes:
measure: Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9
timeFrame: Baseline and weekly from Weeks 1 to 9
measure: Baseline Mean Sleep Interference Score
timeFrame: Baseline
measure: Change From Baseline in Mean Sleep Interference Score at Endpoint
timeFrame: Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)
measure: Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9
timeFrame: Baseline and weekly from Weeks 1 to 9
measure: Percentage of 30 Percent (%) Responders at Endpoint
timeFrame: End of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)
measure: Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9
timeFrame: Baseline; Weeks 1, 5, and 9
measure: Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale
timeFrame: Baseline
measure: Change From Baseline in Pain VAS From the SF-MPQ at Endpoint
timeFrame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
measure: Change From Baseline in PPI Scale From the SF-MPQ at Endpoint
timeFrame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
measure: Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores
timeFrame: Baseline
measure: Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint
timeFrame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
measure: Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint
timeFrame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
measure: Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint
timeFrame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
measure: Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint
timeFrame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
measure: Percentage of Participants Who Had Optimal Sleep at Endpoint
timeFrame: Day 63 (Week 9)/Early Termination (Study Endpoint)
measure: Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint
timeFrame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
measure: Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint
timeFrame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
measure: Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint
timeFrame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
measure: Clinical Global Impression of Change (CGIC) at Endpoint
timeFrame: Day 63 (Week 9)/Early Termination (Study Endpoint)
measure: Patient Global Impression of Change (PGIC) Score at Endpoint
timeFrame: Day 63 (Week 9)/Early Termination (Study Endpoint)
measure: Baseline Hospital Anxiety and Depression Scale (HADS) Scores
timeFrame: Baseline
measure: Change From Baseline in HADS Anxiety Total Score at Endpoint
timeFrame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
measure: Change From Baseline in HADS Depression Total Score at Endpoint
timeFrame: Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint)
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest hospital of the third military medical university/Department of Neurology
state: Chongqing
city: Fuzhou
country: China
facility: Fuzhou General Hospital of Nanjing Military Command
state: Fujian
city: Guangzhou
country: China
facility: Department of Endocrinology, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Harbin
country: China
facility: Dept. of Endocrinology, The first Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: Dept. of Endocrinology, The second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Wuhan
country: China
facility: Tongji Hospital,Tongji Medical College Huazhong University of Science & Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital of Centre-south University
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: Dept. of Endocrinology, The second hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Shengjing hospital of china medical university
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University/department of internal neurology
state: Shandong
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University College of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, School of medicine, Zhejiang University
state: Zhejiang
city: Beijing
country: China
facility: Beijing Tiantan Hospital affiliated to Capital Medical University, Neurology Department
city: Beijing
country: China
facility: Peking University Third Hospital
city: Beijing
country: China
facility: Endocrinology Department
city: Beijing
country: China
facility: Beijing Hospital of the Ministry of Health
city: Beijing
country: China
facility: Tongren Hospital Affiliated to Capital Medical University
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Guangzhou
country: China
facility: GuangZhou First Municipal People's Hospital
city: Shang Hai
country: China
facility: Huashan Hospital Affiliated Fudan University, Neurology Department
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital/The Endocrinology Department
city: Shanghai
country: China
facility: Shanghai First People's Hospital
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiao Tong University School of Medicine/Neurology Department
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: