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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00631943

Enrollment

112

Registered

2008-03-10

Start date

2004-11-30

Completion date

2005-03-31

Last updated

2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuralgia

Brief summary

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

Interventions

DRUGPregabalin (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 design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) visual analog score (VAS)	Weeks 1 and 2 and end of treatment
Change from baseline in weekly mean pain scores	Weeks 1 and 2 and end of treatment

Secondary

Measure	Time frame
Change from baseline in weekly mean sleep interference score	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	Weeks 1 and 2 and end of treatment
Change from baseline in Euro Quality of Life Questionnaire (EQ-5D) scores	End of treatment
Change from baseline in Clinical Global Impression of Change (CGIC)	Weeks 1 and 2 and end of treatment
Change from baseline in pain interference scores on the Brief Pain Inventory (BPI ) Short-Form	End of treatment
Change from baseline in Patient Global Impression of Change (PGIC)	Weeks 1 and 2 and end of treatment
Adverse events and laboratory value changes	Weeks 1 and 2 and end of treatment

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026