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

January 21, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

309

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Pfizer Investigational Site
      • Cheng Du Si Chaun, China
        • Pfizer Investigational Site
      • Guang Zhou, China
        • Pfizer Investigational Site
      • Nan Jing, Jiang Su, China
        • Pfizer Investigational Site
      • Qing Dao Shan Dong, China
        • Pfizer Investigational Site
      • Shang Hai, China
        • Pfizer Investigational Site
      • Shanghai, China
        • Pfizer Investigational Site
      • Tian Jin, China
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
The secondary efficacy parameters include the weekly mean pain scores from the subject's daily pain diaries
The Short Form McGill Pain Questionnaire
The Sleep interference score (from subject pain diary)
The Clinician and Patient Global Impression of Change (CGIC and PGIC)
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.
Addtionally, the safety and tolerability of Pregabalin will also be evaluated.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion (ACTUAL)

September 1, 2007

Study Registration Dates

First Submitted

March 7, 2006

First Submitted That Met QC Criteria

March 9, 2006

First Posted (ESTIMATE)

March 10, 2006

Study Record Updates

Last Update Posted (ACTUAL)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0081081

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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