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

NCT00301223 | Completed Phase 3

• 1 other identifier: A0081081
• Study Type: interventional
• Target: 309
• Locations: 1 country
• Sites: 7

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.

Conditions

Neuropathic Pain

Outcome Measures

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 (6)

• 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.

Interventions

Pregabalin DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (7)

Pfizer Investigational Site

Beijing, China

Location

Pfizer Investigational Site

Cheng Du Si Chaun, China

Location

Pfizer Investigational Site

Guangzhou, China

Location

Pfizer Investigational Site

Nan Jing, Jiang Su, China

Location

Pfizer Investigational Site

Qing Dao Shan Dong, China

Location

Pfizer Investigational Site

Shanghai, China

Location

Pfizer Investigational Site

Tianjin, China

Location

Related Publications (2)

• 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.

  PMID: 28072797 DERIVED

• 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.

  PMID: 27611736 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Neuralgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2006
• First Posted: March 10, 2006
• Study Start: February 1, 2006
• Study Completion: September 1, 2007
• Last Updated: January 22, 2021

Record last verified: 2011-05

Locations

CN (7)