Trial of Efficacy and Safety of Pregabalin in Subjects With Neuropathic Pain Associated With Lumbo-Sacral Radiculopathy

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00159705
First received: September 8, 2005
Last updated: October 9, 2008
Last verified: October 2008
  Purpose

Trial will evaluate the efficacy and safety of pregabalin in the treatment of subjects with neuropathic pain associated with lumbo-sacral radiculopathy.


Condition Intervention Phase
Radiculopathy
Drug: pregabalin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects With Neuropathic Pain Associated With Lumbo-Sacral Radiculopathy

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Pain measurement

Enrollment: 276
Study Start Date: April 2005
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pain consistent with a diagnosis of chronic lumbo-sacral radiculopathy due to spinal stenosis or disk herniation.
  • Radicular pain must be present for at least 3 months and pain stable for at least 4 weeks.

Exclusion Criteria:

  • Surgery for lumbo-sacral radiculopathy within previous 6 months and/or more than one previous spinal surgery for pain-radiculopathy.
  • Epidural injection for lumbo-sacral radiculopathy within previous 6 weeks and/or anticipated need for treatment with opioid analgesics, anti-epileptic medications or tricyclic antidepressants to alleviate pain due to lumbo-sacral radiculopathy during the course of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159705

  Show 52 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director Clinical Trials Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00159705     History of Changes
Other Study ID Numbers: A0081007
Study First Received: September 8, 2005
Last Updated: October 9, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neuralgia
Radiculopathy
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014