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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01332149
First received: April 7, 2011
Last updated: June 27, 2014
Last verified: June 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 ]

Enrollment: 626
Study Start Date: July 2011
Study Completion Date: April 2014
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332149

  Show 32 Study Locations
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: June 27, 2014
Health Authority: United States: 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
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Signs and Symptoms
Gamma-Aminobutyric Acid
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
GABA Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014