Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00631943
Previous Study | Return to List | Next Study

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

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.
 
ClinicalTrials.gov Identifier: NCT00631943
Recruitment Status : Completed
First Posted : March 10, 2008
Last Update Posted : April 26, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 3, 2008
First Posted Date  ICMJE March 10, 2008
Last Update Posted Date April 26, 2011
Study Start Date  ICMJE November 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2008)
  • 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 intereference scores on the Brief Pain Inventory (BPI ) Short-Form [ Time Frame: End of treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of Pregabalin (Lyrica) for the Treatment of Nerve Pain
Official Title  ICMJE An Open Label, Non-comparative, Multicentre Study to Evaluate the Efficacy and Tolerability of Pregabalin in Peripheral Neuropathic Pain
Brief Summary The purpose of this study is to evaluate the efficacy and safety of Lyrica in Indian patients with nerve pain
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neuralgia
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Pregabalin (Lyrica)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2011)
112
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2008)
111
Actual Study Completion Date  ICMJE March 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00631943
Other Study ID Numbers  ICMJE A0081068
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP