search
Back to results

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

Primary Purpose

Neuropathic Pain

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Pregabalin
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
March 7, 2006
Last Updated
January 21, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00301223
Brief Title
A Study to Assess the Efficacy, Safety and Tolerability of Pregabalin in Patients With Symptoms of Neuropathic Pain
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
309 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pregabalin
Primary Outcome Measure Information:
Title
The primary efficacy parameter is the endpoint mean pain score based on the pain scores from the subject's daily pain diaries.
Secondary Outcome Measure Information:
Title
The secondary efficacy parameters include the weekly mean pain scores from the subject's daily pain diaries
Title
The Short Form McGill Pain Questionnaire
Title
The Sleep interference score (from subject pain diary)
Title
The Clinician and Patient Global Impression of Change (CGIC and PGIC)
Title
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.
Title
Addtionally, the safety and tolerability of Pregabalin will also be evaluated.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Beijing
Country
China
Facility Name
Pfizer Investigational Site
City
Cheng Du Si Chaun
Country
China
Facility Name
Pfizer Investigational Site
City
Guang Zhou
Country
China
Facility Name
Pfizer Investigational Site
City
Nan Jing, Jiang Su
Country
China
Facility Name
Pfizer Investigational Site
City
Qing Dao Shan Dong
Country
China
Facility Name
Pfizer Investigational Site
City
Shang Hai
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
Country
China
Facility Name
Pfizer Investigational Site
City
Tian Jin
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
28072797
Citation
Schug SA, Parsons B, Almas M, Whalen E. Effect of Concomitant Pain Medications on Response to Pregabalin in Patients with Postherpetic Neuralgia or Spinal Cord Injury-Related Neuropathic Pain. Pain Physician. 2017 Jan-Feb;20(1):E53-E63.
Results Reference
derived
PubMed Identifier
27611736
Citation
Markman JD, Jensen TS, Semel D, Li C, Parsons B, Behar R, Sadosky AB. Effects of Pregabalin in Patients with Neuropathic Pain Previously Treated with Gabapentin: A Pooled Analysis of Parallel-Group, Randomized, Placebo-controlled Clinical Trials. Pain Pract. 2017 Jul;17(6):718-728. doi: 10.1111/papr.12516. Epub 2016 Dec 1.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081081&StudyName=A+Study+to+Assess+the+Efficacy%2C+Safety+and+Tolerability+of+Pregabalin+in+Patients+with+Symptoms+of+Neuropathic+Pain
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs