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

Neuropathic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00301223
• Other study ID #: A0081081
• Status: Completed
• Phase: Phase 3
• Start date: February 2006
• Est. completion date: September 2007

Study information

• Verified date: May 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• Pregabalin

Locations

Country	Name	City	State
China	Pfizer Investigational Site	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

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

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

External Links

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