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NCT Number: NCT00301223

A Study to Assess the Efficacy, Safety and Tolerability of Pregabalin in Patients With Symptoms of Neuropathic Pain

The objective of this study is to evaluate the efficacy, safety and tolerability for pregabalin using a flexible, optimized dose schedule compared to placebo in relieving the symptoms of neuropathic pain.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Beijing, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chinese outpatient of age 18 to 75
  • At screening and baseline, a score of greater than 40 mm on the visual log scale of SF-MPQ

Exclusion criteria

  • Neurologic disorders unrelated to neuropathic pain, which in the opinion of the investigator, might impair the assessment of pain
  • Serum creatinine clearance greater than 60 ml/min

Treatment and study plan

Pregabalin

Drug

Primary outcomes

  1. The primary efficacy parameter is the endpoint mean pain score based on the pain scores from the subject's daily pain diaries.

Secondary outcomes

  1. The secondary efficacy parameters include the weekly mean pain scores from the subject's daily pain diaries

  2. The Short Form McGill Pain Questionnaire

  3. The Sleep interference score (from subject pain diary)

  4. The Clinician and Patient Global Impression of Change (CGIC and PGIC)

  5. The responder rate defined as the proportion of subjects reporting a decrease of at least 30% in the weekly mean pain scores in each treatment group.

  6. Addtionally, the safety and tolerability of Pregabalin will also be evaluated.

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Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

An 8-Week Multi-Center, Randomized, Double Blind, Placebo-Controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (150mg-600mg/Day) Using A Flexible Dosing Schedule In The Treatment Of Subjects With Symptoms Of Neuropathic Pain

Important dates

Study start
2006
Study completion
2007
First posted
Mar 10, 2006
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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