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OpenTrials
Completed

NCT Number: NCT00631943

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

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

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Key information

Conditions

Neuralgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Bangalore, Karnataka, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

pregabalin (Lyrica)

Drug

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.

Primary outcomes

  1. 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

  2. Change from baseline in weekly mean pain scores

    Time frame: Weeks 1 and 2 and end of treatment

Secondary outcomes

  1. Change from baseline in Euro Quality of Life Questionnaire (EQ-5D) scores

    Time frame: End of treatment

  2. Adverse events and laboratory value changes

    Time frame: Weeks 1 and 2 and end of treatment

  3. Change from baseline in weekly mean sleep interference score

    Time frame: Weeks 1 and 2 and end of treatment

  4. 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

  5. Change from baseline in Patient Global Impression of Change (PGIC)

    Time frame: Weeks 1 and 2 and end of treatment

  6. Change from baseline in Clinical Global Impression of Change (CGIC)

    Time frame: Weeks 1 and 2 and end of treatment

  7. Change from baseline in pain interference scores on the Brief Pain Inventory (BPI ) Short-Form

    Time frame: End of treatment

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Mar 10, 2008
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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