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

Neuralgia Clinical Trial

Official title:

An Open Label, Non-comparative, Multicentre Study to Evaluate the Efficacy and Tolerability of Pregabalin in Peripheral Neuropathic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00631943
• Other study ID #: A0081068
• Status: Completed
• Phase: Phase 3
• Start date: November 2004
• Est. completion date: March 2005

Study information

• Verified date: April 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Neuralgia

Intervention

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.

Locations

Country	Name	City	State
India	Pfizer Investigational Site	Bangalore	Karnataka / India
India	Pfizer Investigational Site	Bangalore	Karnataka
India	Pfizer Investigational Site	Chennai	Tamil Nadu
India	Pfizer Investigational Site	Chennai	Tamil, Nadu
India	Pfizer Investigational Site	Maharashtra	Mumbai
India	Pfizer Investigational Site	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) visual analog score (VAS)		Weeks 1 and 2 and end of treatment
Primary	Change from baseline in weekly mean pain scores		Weeks 1 and 2 and end of treatment
Secondary	Change from baseline in Euro Quality of Life Questionnaire (EQ-5D) scores		End of treatment
Secondary	Adverse events and laboratory value changes		Weeks 1 and 2 and end of treatment
Secondary	Change from baseline in weekly mean sleep interference score		Weeks 1 and 2 and end of treatment
Secondary	Change from baseline in sensory, affective, and total components of the pain descriptor score and the Present Pain Intensity (PPI) of the SF-MPQ		Weeks 1 and 2 and end of treatment
Secondary	Change from baseline in Patient Global Impression of Change (PGIC)		Weeks 1 and 2 and end of treatment
Secondary	Change from baseline in Clinical Global Impression of Change (CGIC)		Weeks 1 and 2 and end of treatment
Secondary	Change from baseline in pain interference scores on the Brief Pain Inventory (BPI ) Short-Form		End of treatment

External Links

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