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A Study to Evaluate the Efficacy and Safety of Pregabalin (Lyrica) for the Treatment of Nerve Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00631943
First Posted: March 10, 2008
Last Update Posted: April 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
The purpose of this study is to evaluate the efficacy and safety of Lyrica in Indian patients with nerve pain

Condition Intervention Phase
Neuralgia Drug: Pregabalin (Lyrica) Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Non-comparative, Multicentre Study to Evaluate the Efficacy and Tolerability of Pregabalin in Peripheral Neuropathic Pain

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) visual analog score (VAS) [ Time Frame: Weeks 1 and 2 and end of treatment ]
  • Change from baseline in weekly mean pain scores [ Time Frame: Weeks 1 and 2 and end of treatment ]

Secondary Outcome Measures:
  • Change from baseline in Euro Quality of Life Questionnaire (EQ-5D) scores [ Time Frame: End of treatment ]
  • Adverse events and laboratory value changes [ Time Frame: Weeks 1 and 2 and end of treatment ]
  • Change from baseline in weekly mean sleep interference score [ Time Frame: Weeks 1 and 2 and end of treatment ]
  • Change from baseline in sensory, affective, and total components of the pain descriptor score and the Present Pain Intensity (PPI) of the SF-MPQ [ Time Frame: Weeks 1 and 2 and end of treatment ]
  • Change from baseline in Patient Global Impression of Change (PGIC) [ Time Frame: Weeks 1 and 2 and end of treatment ]
  • Change from baseline in Clinical Global Impression of Change (CGIC) [ Time Frame: Weeks 1 and 2 and end of treatment ]
  • Change from baseline in pain interference scores on the Brief Pain Inventory (BPI ) Short-Form [ Time Frame: End of treatment ]

Enrollment: 112
Study Start Date: November 2004
Study Completion Date: March 2005
Arms Assigned Interventions
Experimental: 1 Drug: Pregabalin (Lyrica)
Oral pregabalin (Lyrica) capsules, initial dose of 75 mg twice daily, which could be increased to 300 mg twice daily at the discretion of the investigator. Patients were treated for up to 21 days.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Peripheral neuropathic pain
  • Score of at least 40 mm on the VAS of the SF-MPQ at screening and baseline
  • Completion of at least 4 daily pain diary entries with an average daily pain score of at least 4 over the 7 days prior to baseline

Exclusion criteria:

(none)

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631943


Locations
India
Pfizer Investigational Site
Bangalore, Karnataka / India, India, 560 034
Pfizer Investigational Site
Bangalore, Karnataka, India, 560054
Pfizer Investigational Site
Mumbai, Maharashtra, India, 400 012
Pfizer Investigational Site
Maharashtra, Mumbai, India, 400 007
Pfizer Investigational Site
Chennai, Tamil Nadu, India, 600 004
Pfizer Investigational Site
Chennai, Tamil, Nadu, India, 600 013
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00631943     History of Changes
Other Study ID Numbers: A0081068
First Submitted: March 3, 2008
First Posted: March 10, 2008
Last Update Posted: April 26, 2011
Last Verified: April 2011

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs