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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetic Neuropathy, Painful

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

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

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

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.

Clinical Details

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

Primary outcome:

Baseline Mean Pain Score

Change From Baseline in Mean Pain Score at Endpoint

Secondary outcome:

Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9

Baseline Mean Sleep Interference Score

Change From Baseline in Mean Sleep Interference Score at Endpoint

Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9

Percentage of 30 Percent (%) Responders at Endpoint

Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9

Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale

Change From Baseline in Pain VAS From the SF-MPQ at Endpoint

Change From Baseline in PPI Scale From the SF-MPQ at Endpoint

Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores

Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint

Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint

Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint

Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint

Percentage of Participants Who Had Optimal Sleep at Endpoint

Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint

Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint

Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint

Clinical Global Impression of Change (CGIC) at Endpoint

Patient Global Impression of Change (PGIC) Score at Endpoint

Baseline Hospital Anxiety and Depression Scale (HADS) Scores

Change From Baseline in HADS Anxiety Total Score at Endpoint

Change From Baseline in HADS Depression Total Score at Endpoint

Eligibility

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.

Locations and Contacts

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

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

Chinese PLA General Hospital, Beijing 100853, China

Endocrinology Department, Beijing 100700, China

Peking University Third Hospital, Beijing 100191, China

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

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

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

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

Shanghai Changzheng Hospital, Shanghai 200003, China

Shanghai First People's Hospital, Shanghai 200080, China

Shanghai Tenth People's Hospital/The Endocrinology Department, Shanghai 200072, China

Southwest hospital of the third military medical university/Department of Neurology, Chongqing, Chongqing 400038, China

Fuzhou General Hospital of Nanjing Military Command, Fuzhou, Fujian 350025, China

Department of Endocrinology, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Guangzhou, Guangdong 510120, China

Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong 510515, China

The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510260, China

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

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

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

Xiangya Hospital of Centre-south University, Changsha, Hunan 410008, China

Jiangsu Province Hospital, Nanjing, Jiangsu 210029, China

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

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

Shengjing hospital of china medical university, Shenyang, Liaoning 110004, China

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

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

Tianjin Medical University General Hospital, Tianjin, Tianjin 300052, China

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

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

Additional Information

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

Starting date: July 2011
Last updated: June 1, 2015

Page last updated: August 23, 2015

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