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

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:

Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Diabetic Nerve Problems Peripheral Nerve Disorders

Drug Information available for: Pregabalin

U.S. FDA Resources

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:	February 2014
Estimated Primary Completion Date:	February 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.

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

Show 30 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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:	May 23, 2013
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 June 18, 2013