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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

March 3, 2008
April 22, 2011
November 2004
Not Provided
  • 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 ]
Same as current
Complete list of historical versions of study NCT00631943 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 intereference scores on the Brief Pain Inventory (BPI ) Short-Form [ Time Frame: End of treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study to Evaluate the Efficacy and Safety of Pregabalin (Lyrica) for the Treatment of Nerve Pain
An Open Label, Non-comparative, Multicentre Study to Evaluate the Efficacy and Tolerability of Pregabalin in Peripheral Neuropathic Pain

The purpose of this study is to evaluate the efficacy and safety of Lyrica in Indian patients with nerve pain

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neuralgia
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.
Experimental: 1
Intervention: Drug: Pregabalin (Lyrica)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
March 2005
Not Provided

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)

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00631943
A0081068
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2011

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