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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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00631943
First received: March 3, 2008
Last updated: April 22, 2011
Last verified: April 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Change from baseline in weekly mean pain scores [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Euro Quality of Life Questionnaire (EQ-5D) scores [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
  • Adverse events and laboratory value changes [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: Yes ]
  • Change from baseline in weekly mean sleep interference score [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in Patient Global Impression of Change (PGIC) [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: No ]
  • Change from baseline in Clinical Global Impression of Change (CGIC) [ Time Frame: Weeks 1 and 2 and end of treatment ] [ Designated as safety issue: No ]
  • Change from baseline in pain interference scores on the Brief Pain Inventory (BPI ) Short-Form [ Time Frame: End of treatment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00631943     History of Changes
Other Study ID Numbers: A0081068
Study First Received: March 3, 2008
Last Updated: April 22, 2011
Health Authority: India: Drugs Controller General of India

Additional relevant MeSH terms:
Pregabalin
Analgesics
Anticonvulsants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014