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

This study is currently recruiting participants.
Verified March 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01332149
First received: April 7, 2011
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Diabetic Neuropathy, Painful
Drug: Pregabalin
Drug: Placebo matched with pregabalin
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Endpoint mean pain score based on the pain scores from the subject's daily pain rating scale [ Time Frame: From baseline to week 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weekly mean pain scores from the subject's daily pain rating scale [ Time Frame: End of week 1, 2, 3, 4, 5, 6, 7, 8, 9 ] [ Designated as safety issue: No ]
  • Weekly mean sleep interference scores from the subject's daily sleep interference scale [ Time Frame: End of week 1, 2, 3, 4, 5, 6, 7, 8, 9 ] [ Designated as safety issue: No ]
  • Responder rates with at least a 30% reduction from baseline in weekly mean pain score [ Time Frame: From baseline to week 9 ] [ Designated as safety issue: No ]
  • Change from baseline in Short-Form McGill Pain Questionnaire at week 9 [ Time Frame: From baseline to week 9 ] [ Designated as safety issue: No ]
  • Change from baseline in Pain Visual Analogue Scale at week 9 [ Time Frame: From baseline to week 9 ] [ Designated as safety issue: No ]
  • Change from baseline in Medical Outcomes Study -Sleep Scale at week 9 [ Time Frame: From baseline to week 9 ] [ Designated as safety issue: No ]
  • The Subject Global Impression of Change at week 9 [ Time Frame: From baseline to week 9 ] [ Designated as safety issue: No ]
  • The Clinical Global Impression of Change at week 9 [ Time Frame: From baseline to week 9 ] [ Designated as safety issue: No ]
  • Change from baseline in Hospital Anxiety and Depression Scale at week 9 [ Time Frame: From baseline to week 9 ] [ Designated as safety issue: No ]

Estimated Enrollment: 612
Study Start Date: July 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 300 mg/day pregabalin (Lyrica)
Patient take pregabalin capsule twice a day
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.

Placebo Comparator: Placebo Drug: Placebo matched with pregabalin
Subject will take placebo matched with pregabalin twice a day.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332149

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
China, Beijing
The second artillery general hospital of PLA Recruiting
Beijing, Beijing, China, 100088
China, Chongqing
Southwest hospital of the third military medical university/Department of Neurology Active, not recruiting
Chongqing, Chongqing, China, 400038
China, Fujian
Fuzhou General Hospital of Nanjing Military Command Recruiting
Fuzhou, Fujian, China, 350025
China, Guangdong
The Second Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510260
Department of Endocrinology, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510120
Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
China, Heilongjiang
Dept. of Endocrinology, The second Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150086
Dept. of Endocrinology, The first Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150001
China, Hubei
Tongji Hospital,Tongji Medical College Huazhong University of Science & Technology Recruiting
Wuhan, Hubei, China, 430030
China, Hunan
Xiangya Hospital of Centre-south University Recruiting
Changsha, Hunan, China, 410008
China, Jiangsu
Jiangsu Province Hospital Recruiting
Nanjing, Jiangsu, China, 210029
China, Jiangxi
The First Affiliated Hospital of Nanchang University Recruiting
Nanchang, Jiangxi, China, 330006
China, Jilin
Dept. of Endocrinology, The second hospital of Jilin University Recruiting
Changchun, Jilin, China, 130041
China, Liaoning
Shengjing hospital of china medical university Recruiting
Shenyang, Liaoning, China, 110004
China, Shandong
Qilu Hospital of Shandong University/department of internal neurology Recruiting
Jinan, Shandong, China, 250012
Qilu Hospital of Shandong University Recruiting
Jinan, Shandong, China, 250012
China, Shanxi
First Hospital of Shanxi Medical University Recruiting
Taiyuan City, Shanxi, China, 030001
China, Tianjin
Tianjin Medical University General Hospital Recruiting
Tianjin, Tianjin, China, 300052
China, Zhejiang
The Second Affiliated Hospital Zhejiang University College of Medicine Active, not recruiting
Hangzhou, Zhejiang, China, 310009
Sir Run Run Shaw Hospital, School of medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310016
China
Tongren Hospital Affiliated to Capital Medical University Recruiting
Beijing, China, 100730
Chinese PLA General Hospital Completed
Beijing, China, 100853
Beijing Tiantan Hospital affiliated to Capital Medical University, Neurology Department Completed
Beijing, China, 100050
Beijing Hospital of the Ministry of Health Recruiting
Beijing, China, 100730
Peking University Third Hospital Recruiting
Beijing, China, 100191
Endocrinology Department Active, not recruiting
Beijing, China, 100700
GuangZhou First Municipal People's Hospital Recruiting
Guangzhou, China, 510180
Huashan Hospital Affiliated Fudan University, Neurology Department Recruiting
Shang Hai, China, 200040
Shanghai Changzheng Hospital Recruiting
Shanghai, China, 200003
Shanghai First People's Hospital Recruiting
Shanghai, China, 200080
Renji Hospital Shanghai Jiao Tong University School of Medicine/Neurology Department Recruiting
Shanghai, China, 200127
Shanghai Tenth People's Hospital/The Endocrinology Department Recruiting
Shanghai, China, 200072
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01332149     History of Changes
Other Study ID Numbers: A0081265
Study First Received: April 7, 2011
Last Updated: March 25, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Pfizer:
Diabetic Neuropathies
Pain
Efficacy of pregabalin
Placebo controlled

Additional relevant MeSH terms:
Diabetic Neuropathies
Pain
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on April 15, 2014